chrisvoncsefalvay/vaers-outcomes huggingface dataset:
FELT RUNDOWN; FELT TIRED; NO ERECTION; WARMTH SENSATION IN THE RIGHT ARM AND WRIST; PAIN IN THE RIGHT ARM; This spontaneous report received from a patient concerned a 59-year old male. The patient's height and weight were not reported.  The patient's past medical history included open heart surgery in 2018, and he had no known allergies. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, and expiry: UNKNOWN) dose was not reported, 1 total dose was administered on 06-MAY-2021 on the right arm as prophylactic vaccination. Concomitant medications included Atorvastatin, Clopidogrel, Diltiazem, Losartan, and Pioglitazone.  On 6-MAY-2021 the patient felt a warm sensation of the vaccine when it was administered in the arm and wrist. He felt soreness in the Right arm that evening. On 7-MAY-2021 his arm felt achy but not as painful. He felt "rundown" until the date of May 10th, or the 11th. On 10-MAY-2021 he observed that he was not able to obtain an erection; however, he was able to ejaculate. From 10-MAY-2021 to 17-MAY-2021 the patient still is not able to obtain an erection.  The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from warmth sensation in the right arm and wrist, pain in the right arm, felt rundown, and felt tired, and had not recovered from no erection. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210532159-covid-19 vaccine ad26.cov2.s-No erection. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Case number PHEH2015US015701 is an initial spontaneous report received from a health care professional on 12 Aug 2015. This report refers to a female patient whose age was not reported. Past medical history and concomitant medications were not reported. The patient received an expired dose of FLUVIRIN (batch number: 1412301A, expiry date: 30 Jun 2015) intradermally instead of tuberculin (TB) skin test (other manufacturer, batch number: not reported) on 12 Aug 2015. It was reported that patient had a big welt at the vaccination site on the same date. The outcome, seriousness and causality of welt were not reported. No further information was provided.
At the site: soreness, redness, bruising, swelling, a red ring around the site.
Dizziness, headache, sore neck, slight heart pressure, body aches, fatigue, vacillating body temperatures (96.2-100.4 F}.
within 48 hours L inflamed supraclavicular lymph node present; left shoulder pain; This is a spontaneous report from a contactable Physician. A 37-year-old female physician received first single dose of BNT162B2 (Pfizer/ BioNTech Covid-19 vaccine, Lot number EK5730) intramuscularly at her left arm at 11:00 AM on 17Dec2020 for COVID-19 immunization in her workplace clinic. The patient had a medical history of hypertension, generalized anxiety, hyperlipidemia and obesity. The patient had no known allergies to medications, food, or other products. Other medications in two weeks included chlorthalidone, fluoxetine hydrochloride (PROZAC), and lansoprazole. No vaccines were received within four weeks. Within 48 hours of the vaccination, on 19Dec2020, left inflamed supraclavicular lymph node present, and it persisted for 1 week with left shoulder pain. Lymph node was still present but nontender on 05Jan2021. Her 2nd dose due 07Jan2021. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The patient was recovering from the events. The patient considered that the events were non-serious.
Possible interaction with Coumadin and Vimpat May 17th HFH  with AFIB June 1st HFH with Congestive Heart Failure July 10th with hemorrhagic stroke
Left arm soreness, swelling, warmth around injection site.  Headache, body aches. Fever the whole day and night of 8/6/22, inspite if me taking tylenol 500 mg x 2.
While lying down he has noticed pressure in his chest along with self limited episodes of feeling like his heart is beating fast.   Feels better sitting up.   Vaguely shortness of breath.   No dyspnea on exertion.   No nausea and vomiting.   No diaphoresis.   No radiation to neck, arm or jaw.   No extremity pain or swelling.   Non exertional.   No extremity pain or swelling.   No abdominal pain.   No history of reactive airway disease.   No tobacco use.  He has not had this problem before.  These symptoms have continued for a full year, though with lesser frequency and severity, since initial dose of MRNA vaccine.
I felt like my stomach was going to explode the day after getting the vaccine.  The amount of pressure in my belly, it felt like something was going to burst.  I was able to throw up 5x, which relieved some pressure, but I was still very uncomfortable.  Yesterday and Today (Day 3 & 4 post vaccination shot), I have been monitoring the pain in my stomach, and the pain has traveled to the lower-right portion of my stomach.  I am afraid my appendix is going to burst.  I?m going to see a Dr today.  I believe this is very unfair to me, an essential employee, who never contracted Covid-19 while still attending work over the last year, I was encouraged to take the vaccination shot by the state and my employer, and now I?m afraid I will need surgery.  Please look in to this.
The day after he received the vaccine (the 4th) he developed aching and "flu like symptoms". By Friday (the 7th) he had shortness of breath and back pain and was diagnosed with bilateral pleural effusions.
Patient had received 1 dose of Johnson and Johnson on 3/24/21 and received a moderna covid dose (0.5ml)on 8/23/21. No adverse outcomes noted. No additional treatment needed.
Developed a rash on right forearm with numbness in right hand and fingers. Took 25mg of Benedryl 45 minute prior to shot due to adverse reactions then. Took 25 mg Benadryl at 12pm after noticing rash and feeling numbness in hand/fingers.
pt recv vax 13MAY97 & 23MAY97 pt devel chickenpox w/lesion all over back & forearms;
At 16:38, the patient reported feeling hives, however denies shortness of breath or feelings of closing airway. Benadryl administered PO, and vitals were taken. Fluids provided. Nurse noted redness to left upper chest, however did not worsen within 30 minutes monitoring period. Second set of vitals taken before patient left monitoring. The patient denied any shortness of breath, feelings of closing airway, or anaphylaxis-type reactions upon leaving. Patient educated to monitor symptoms, take additional Benadryl PO as needed, and to stay hydrated.
3-25-21 approx(pt unsure) lump on collar bone. Left sided of face swollen around week three. after 2nd dose lump behind the ear. Had sonogram done and was told it was an infected salivary gland.
Received vaccine around 8 am, arm soreness within 4 hours of administration.  At midnight (16 hours after administration), woke up with chills, body aches, headache, hands and feet hot, skin hot to touch/tactile fever.
Symptoms appeared evening of 5/30/08 - sore arm.  Morning of 5/31/08 arm severely swollen, red and hot, fever (100 F) and rash over body.  Symptoms lasted until 6/3/08.  Treatment - Tylenol and heat pack.
Had injection on 3/16/2021 at 9:45 AM.  Pain in Right Arm at injection site began about 5 hours later.  Started taking Tramadol for pain on 3/17.  Noticed rash on arm on 3/19.  Pain has continued constantly for 9 days including today 3/25/2021. Pain level is mild when controlled with Tramadol.
bad case of jet lag; glands under my arms got very sore; lumps under my arms; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 26Mar2021 14:00 (Batch/Lot Number: EP6955) as single dose for covid-19 immunisation at a workplace clinic. The patient's medical history was not reported. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included losartan and sertraline hydrochloride (ZOLOFT). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 05Mar2021 for COVID-19 immunization. The patient also previously took codeine and experienced allergies. On 28Mar2021 08:00, the patient felt like a very very bad case of jet lag. Also, the glands under her arms got very sore and felt like there were lumps under her arms. The events were not treated. The outcome of the events was recovering.
I had severe tinnitus 15 years prior from a bad inner ear infection. I habituated to the tinnitus over time to where it was very tolerable. After the COVID-19 vaccine, my tinnitus returned to the severe condition 15 years prior.
Patient reported sore shoulder and difficulty lifting arm. Followed up in one week and patient still had soreness, showed some improvement in range of motion.
All I know is that patient called the pharmacy Friday(06/28/2019) and spoke with the overnight RPh.  She stated that she was having a bad reaction to the engerix b and that she had bruising and pain radiating from the shoulder to the neck.   Several attempts were made to speak with the patient later on Friday, but I was unable to reach her.  I called the Doctor and they were closed today for training but would reopen on Saturday and we will try to contact them at that time.  She was told to contact her doctor, but I am unable to confirm that the patient was seen by a health care professional after reporting the effects.
3 hrs p/receiving vax pt devel fver of 103 w/APAP, stiffening & screaming; 1st 24 hrs p/vax needed constant walking & bouncing to stay quiet; 24 hrs p/vax had vomiting for 24 hrs then fussy 1 day;
Pt exp abn drowsiness & reduced interest p/1st inject, fever, swelling @ inject site; w/in 24 hrs p/2nd inject 14OCT pt had abn jerking & aching of back, w/in 3 days abn sleepiness, glassy stare, & loss interest, t102, severe sz, handicapp;
Right thigh (inject site) erythema & induration 21 cm x 10 cm, Left thigh erythema & induration 11 cm x 5 cm, Child alert, afebrile, ambulatory
Thought I was well protected. Wrong!!!!! / heading into my 3rd month of pain & suffering; Thought I was well protected. Wrong!!!!! / heading into my 3rd month of pain & suffering; I am heading into my 3rd month of pain; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, several years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. It was reported that the patient has taken the first vaccination that came out. A couple of years before the date of reporting, the patient took the two new vaccine's that came out. The patient experienced shingles and stated that the patient was heading into my 3rd month of pain and suffering. The patient stated that the patient was wrong that patient was well protected. This case was considered to be a suspected vaccination failure case, as the details regarding being laboratory confirmation for shingles was unknown. This case has been linked with the case US2021AMR063296, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR063296:Same reporter.
experienced some itching; This case was reported by a consumer via interactive digital media and described the occurrence of pruritus in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In August 2022, the patient received Shingles vaccine. In August 2022, less than a week after receiving Shingles vaccine, the patient experienced pruritus. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the pruritus was not recovered/not resolved.   It was unknown if the reporter considered the pruritus to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 24-AUG-2022 Reporter's Comments: This case was received from patient via interactive digital media. The patient got his/her Shingles shot two days ago from reporting and experienced some itching.  The patient did not had shingles, but the shot had made him/her itchy person. The patient just had the shot and now he/she was itching like crazy. Benadryl had not calm it down yet. The place of the injection did not hurt at all. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Beginning night of vaccination, developed induration erythema at site and fever 103.8 more than a day. 4 days later symptoms are improving.
Day 1- RUE injection site tender Day2- RUE Large knot at injection site, tenderness. Fatigue Day 3- Right Axillary lymph nodes swelling, grapefruit size, painful. Edema from injection site to fingertips with numbness to 3,4,5 digits. Fatigue and headache. Day 4- RIGHT sided lymph nodes swelling, palpable to neck, axillary and groin. Severe fatigue. Headache.  Edema still complete to RUE- with numbness to fingers. Grapefruit sized axillary, slightly improved.  NO FEVER, COUGH, DYSPNEA
she developed swelling in her lymph nodes; This is a spontaneous report from a contactable consumer. This consumer (patient reported for herself):  A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EN6206), via unspecified route of administration, in left arm on 15Mar2021 10:15 (at the age of 36-year-old) as a dose 1, single and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EW0150), via unspecified route of administration, in left arm on 11Apr2021 10:15 as a dose 2, single for COVID-19 immunization. The patient medical history included Crohn's disease. The concomitant medication of the patient included mesalamine (MESALAMINE). On 22Mar2021 the patient experienced swelling in her lymph nodes. The patient stated that 7 days after her first Pfizer COVID vaccine, she developed swelling in her lymph nodes, mainly in the clavicle area. It went down, and it was persisting. Patient stated that yes, I still have it, just persisting, it's less swollen but it is still persisting. It had been about 30 days. Patient was asking if she should seek medical attention. Patient stated that she had her second shot on 11Apr2021. Patient reported that she recently got second vaccine but prior to the second vaccine, the first one patient just noticed in about may be in week or so she just developed some swollen lymph node on her lower neck or on her clavicle area and wanted to ask is that something that should go away soon or it's going to take some time. Patient also stated that she had done blood work don't know the exact date but in early March. She read about the side effects which said that that could occur. Patient wanted to know if she should she seek medical assistance or wait a couple of weeks. Patient was informed about a Safety report and patient stated that she had already spoke with someone from another department today who ask her questions and was told she needed to contact the safety department as well. Patient was ok to report her experience. Patient not received any treatment for the reported event. On an unspecified date of Mar2021 the patient underwent lab tests and procedures which included Blood test (blood work) with unknown results. Outcome for the reported event was recovering.  No follow-up attempts are needed. No further information is expected.
The man walked approximately 30 feet and collapsed/fainted; Extremely diaphoretic; This is a spontaneous report from a non-contactable consumer (volunteer at a vaccination clinic) reporting for a patient. A male adult in his 30's received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number and expiry date unknown) via an unspecified route of administration on 07Feb2021 around 15:00 at a single dose for COVID-19 immunization. No information about the patient's medical history and concomitant drugs was provided. After receiving the vaccine, the man walked approximately 30 feet and collapsed. The onsite supervisor from the institute indicated that he was extremely diaphoretic and had "fainted" before he could reach the post-vaccination observation area. EMS (Emergency Medical Services) was stationed onsite and assisted the man. The man was placed in a chair for approximately 15 minutes. An electrocardiogram (ECG) appeared to have been performed. The man was then transported to the hospital for further evaluation of concussion as it was believed that his head might have impacted a table and/or the floor when he collapsed. It was not specified if the patient was admitted to the hospital. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Almost immediate swelling entire upper leg, and fever and forty-eight later. Persistent vomiting.
Due to Covid, never got 2nd shot; This case was reported by a consumer via call center representative and described the occurrence of social problem in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2020 or perhaps in 2019).   On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.       Additional Information: GSK Receipt Date: 17-FEB-2023 Reporter's Comment: The patient was self-reported this case. The patient first contacted GSK via Web. The patient reported that he recalled that he received his first dose of Shingrix vaccine back in early 2020, but the physician had no record.  The patient stated that due to Covid he never received 2nd dose of Shingrix vaccine.  The patient wanted to know that the new script from document shows 2 shots. The patient asked if it was OK already having the first dose more than  2 years ago. The agent made an outbound call to the patient and reported that the patient truly believed that he received the first dose in 2020 or perhaps in 2019, but did not receive the second dose. The patient physician and the patient pharmacy were unable to locate a record of the vaccination. Additional supportive information: As the patient did not receive the second dose of Shingrix vaccine due to Covid pandemic, which led to social problem.
No additional AE reported; PROQUAD was admnistered after temperature excursion; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies, and concomitant medications were not reported.  On 13-AUG-2021, the vaccine measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) experienced a temperature excursion at a temperature of -7.7°C with a time frame of 30 minutes. On 18-AUG-2021, the patient was vaccinated with the second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) 0 .5 milliliter, lot number T036735 with expiration date 28-APR-2022 for prophylaxis (Product storage error) (route of administration and anatomical location was not reported). There was no previous temperature excursions. No additional adverse events (AE) reported.
Janssen COVID-19 Vaccine EUA?  I WAS OUT OF TOWN AND PASSED OUT AND HAD A SEIZURE AND WHEN I FELL I KNOCKED OUT SOME OF MY TEETH AND HIT MY CHIN AND DISLOCATED AND FRACTURED MY SHOULDER. I WAS NOT BREATHING. MY PARTNER SHOOK ME UNTIL I STARTED BREATHING AND SPITTING OUT BLOOD. I WAS TAKEN TO THE HOSPITAL WHERE THEY PUT MY ARM INTO ITS SOCKET.
Patient reported no symptoms day of the vaccination. The patient did note that the vaccine was given lower than normal in the muscle of the arm. When he awoke the next morning the area around the vaccine was warm to the touch, red, swollen and painful. The patient reported a "goose egg" was on his arm. Since Saturday (10/30/2021) the swelling has gone down, but not entirely away. Patient also reported some muscle weakness, but not more than normal reactions to vaccines in the past.
PATIENT RECEIVED VACCINE THAT EXPERIENCED A TEMPERATURE EXCURSION, VACCINE WAS KEPT IN THE REFRIGERATOR FOR MORE THAN 30 DAYS. PATIENT DID NOT HAVE ANY SIDE EFFECTS.
Small lump and erythema right thigh. Improved in 24-48 hours and redness resolved on 7/21/03.
Yf-vax, was administered intramuscular instead of subcutaneous, with no reported adverse event; Initial information received on 09-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 30 years old male patient to whom YELLOW FEVER VACCINE -  [YF-VAX], was administered intramuscular instead of subcutaneous, with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID (BOOSTRIX) for Prophylactic vaccination; and TYPHOID VACCINE POLYSACCH VI (TYPHIM VI) for Prophylactic vaccination.  On an unknown date, the patient received a dose of suspect YELLOW FEVER VACCINE - lot UJ602AA via intramuscular route in unknown administration site.  On 09-Aug-2022 the patient developed a non-serious event of YELLOW FEVER VACCINE -, was administered intramuscular instead of subcutaneous, with no reported adverse event (incorrect route of product administration) (latency: same day) (dose:0.5ml, batch number: UJ602AA  and expiry date: unknown, strength and formulation was unknown) for Immunization.   Action taken with YELLOW FEVER VACCINE (YF-VAX) was not applicable.  Outcome: Unknown  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.
Patient reported dry cough with involuntary coughing and air hunger after Moderna vaccine #1.  Patient was given Benedryl 50 mg PO prior to being vaccinated with Moderna Dose # 2.  No reaction reported.