chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore, itchy, hardened area at the injection site in the shape of circle; sore, itchy, hardened area at the injection site in the shape of circle; sore , itchy , hardened area at the injection site in the shape of circle; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE INDURATION (sore, itchy, hardened area at the injection site in the shape of circle), VACCINATION SITE PRURITUS (sore, itchy, hardened area at the injection site in the shape of circle) and VACCINATION SITE PAIN (sore , itchy , hardened area at the injection site in the shape of circle) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical history was provided by reporter.     On 31-Mar-2021 at 5:50 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021 at 1:00 AM, the patient experienced VACCINATION SITE INDURATION (sore, itchy, hardened area at the injection site in the shape of circle), VACCINATION SITE PRURITUS (sore, itchy, hardened area at the injection site in the shape of circle) and VACCINATION SITE PAIN (sore , itchy , hardened area at the injection site in the shape of circle). At the time of the report, VACCINATION SITE INDURATION (sore, itchy, hardened area at the injection site in the shape of circle), VACCINATION SITE PRURITUS (sore, itchy, hardened area at the injection site in the shape of circle) and VACCINATION SITE PAIN (sore , itchy , hardened area at the injection site in the shape of circle) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information were not provided by the reporter. Concomitant medications were not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Follow up ADR form received and patient demographics, vaccine facility information was added and vaccine administration details (route of administration & body site) were added On 16-Jul-2021: Email correspondence - No new information received
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 14-NOV-2014, the patient was vaccinated with a dose of VARIVAX (Merck), 0.5 ml subcutaneous (lot number and expiration date were not reported) that underwent a temperature excursion. No adverse effect was reported. Additional information has been requested.
On 03/06/2021, I experienced a sharp left chest pain. I had never experienced chest pain before. That night, I felt like a needle was poking me in my chest. I contacted my doctor, on 03/11/2021, and was told to go to the ER at Hospital for a chest x-ray. I went to the ER and had to wait four hours to be taken to the back. They performed an EKG and noticed that the test was abnormal. My blood work came back abnormal also. I also had a stress test w/o nuclear medicine, a stress test with nuclear medicine and an echocardiogram. The chest x-ray came back normal, but the other tests had abnormalities. I stayed in the hospital for 3 days for observation and was never diagnosed with anything. After leaving the hospital, I couldn't resume my daily activities. I needed to spend extra time resting because I would have shortness of breath easily. It took about two weeks before I started to feel like myself again.
Severe pain, right clavicle area 10/14/2021 16:00, worsening and 10/15/2021 spreading to right shoulder, and up right neck.  10/16/2021 swollen sore lymph node right neck,  sore up to right ear, ringing in ears with decreased hearing right ear.
Fever Headache Nausea Body aches Joint pain  Chills Sweats  Fatigue
Large lump appeared right after first dose, continued for several weeks, lanced. Smaller, but lump still continues, won't go away. (5 months later)
A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 37-year-old male. Neither medical history nor concomitant medications were reported. On 24-Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause of the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 12-May-2009: Product Complaint Investigation results.
Pt received vaccines on 11-1-10 age 6 mos. Mother reports area on (L) leg noted at age 9 mos. Mother reports area grew in size and indention got worse. Pt saw Dr on 5/2/11 age 1 year and has referred pt to another doctor for evaluation. (L) lateral thigh has purplish appearing, sunken, non tender area 20 x 25 mm.
On 3/9 in the evening I began chilling and had a fever - this continued through the night and through the  next day.  On 3/11 I felt better but was dizzy and still had headaches but no fever - site of shot has become red with a rash and it itches slightly. And feels warm and tender to the touch.
Recieved vaccine at noon on 1/10/21 was awoken out of sleep from body aches at 1am on 1/11/21.  I had a fever of 103.0 at 3 am which proceeded to come down 45 minutes later and stay at 100.4 until 10 am. During that time I had a pounding headache, nausea, aches, chills and was profusely sweating and shaking with the fever.  Symptoms abruptly ended at noon on 1/11/21. This also occurred with the first dose that I recieved 12/23/20 at 5:30 however the fever and s/s were not quite as bad. This time they were definitely worse and prevented me from doing anything, I am glad I was not scheduled for work.
Fever 102 degrees Stiffneck on left side sore left upper arm dizziness muscle aches Received no treatment nor was client seen by a Dr.
severe diarrhea; severe abdominal pain,still some cramping today; Initial information received on 26-Sep-2023 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves a 50 years old female patient who experienced severe diarrhea and severe abdominal pain,still some cramping today after receiving vaccine influenza quadrival A-B vaccine [Fluzone Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 22-Sep-2023, the patient received a dose of suspect Influenza Quadrival A-B Vaccine Suspension for injection expiry date: 30-Jun-2024 lot UT8038MA via unknown route in the left arm for Immunisation.  On 24-SEP-2023 the patient developed severe diarrhea (diarrhoea) and severe abdominal pain,still some cramping today (abdominal pain) 2 days following the administration of Influenza Quadrival A-B Vaccine.  Reportedly, she received on Friday, 22Sep2023 and by Sunday at 4 AM she had severe diarrhea and severe abdominal pain. She almost went to the Emergency Room but just ate a liquid diet. She had improvement yesterday but still some cramping today and can at least eat some solids today.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events severe diarrhea, severe abdominal pain,still some cramping today.  At time of reporting, the outcome was Recovering / Resolving for the event severe diarrhea and severe abdominal pain,still some cramping today.
TERRIBLE SWELLING & SORENESS, REDNESS, DIZZINESS, MALAISE, GENERAL ILL FEELING
Hair loss/thining at 2 mos after administration of 2nd GARDASIL shot on 7/7/08
Had severe chills, shivering, body aches that started in the evening 1/29/21, and then a fever also started the following day.  I took Tylenol for the symptoms.   As of today,  2/1/21 still have arm pain and swelling at injection site and some body aches.
12-24 hours -- fever, chills, body aches, exhaustion two days later -- severe dizziness, clamminess, felt very faint. Knee pain in right leg inexplicably started. three days later -- leg pain but the rest of symptoms had faded.  eight days later -- still lingering knee pain.
Began feeling unwell around 1 am, with symptoms including uncontrolled chills, generalized body aches, low grade fever 100.1 (baseline always 98.6).  Took 600 mg of Ibuprofen around 4 am, and this morning chills and fever have subsided, body aches are starting to minimize, and feeling generally better 9 am.
AREA THE SIZE OF SOFTBALL ON INJECTION SITE WAS WARM, RED, SWOLLEN AND SORE. DEVELOPED A BLISTER LIKE RASH ABOUT THE SIZE OF A QUARTER IN THE MIDDLE OF THE INJECTION SITE. ALSO GOT SMALL ITCHY RASH IN A LINE LIKE PATTERN ON THE CHEST BELOW BREASTS.
This case was reported by a consumer via call center representative and described the occurrence of nausea in a 66-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (for tolerance of 1st dose refer case US2019GSK004286). On 29th December 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On an unknown date, less than a week after receiving SHINGRIX, the patient experienced nausea, chills, generalized pruritus, tingling, general body pain, blood pressure high and shortness of breath. The patient was treated with Intravenous Fluids. On an unknown date, the outcome of the nausea and chills were recovered/resolved and the outcome of the generalized pruritus, tingling, general body pain, blood pressure high and shortness of breath were not recovered/not resolved. It was unknown if the reporter considered the nausea, chills, generalized pruritus, tingling, general body pain, blood pressure high and shortness of breath to be related to SHINGRIX. Additional details were provided as follows: The patient experienced nausea, chills for 2 days, itching, tingling, pin pricking pain all over her body with no sign of rash or discoloration. The patient also experienced high blood pressure and shortness of breath. The patient was referred to the emergency room and on 3rd January 2019, the patient was seen and administered IV fluids. The patient was tested for infection and then released to home without admission. The reporter had consented to follow up. The case has been linked with case US2019GSK004286 for the same patient reported by the same reporter. Lab Comments: The patient was referred to emergency room and tested for infection.
It's so itchy; I had some rash underneath the vaccinated area and on my lower thigh which got worse; I had some rash underneath the vaccinated area and on my lower thigh which got worse; sleepless nights; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 50-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0171), via an unspecified route of administration, administered in Arm Left on 12Jun2021 13:30 (at age of 50 years old) as single dose for COVID-19 immunisation. Medical history was none. The patient's concomitant medications were none. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. No other vaccine in four weeks. No other medications in two weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0180), administered in Arm Left at 50 years old for COVID-19 immunisation with no reaction. Got 2nd dose on the 12Jun2021 and 2 days after (14Jun2021) patient had some rash underneath the vaccinated area and on lower thigh which got worse until few days later. It's so itchy, though patient has been taking anti-allergy (Allegra) and tried over the counter anti-itch lotion, the itch didn't go away. Until today, it's still itchy and it reached down legs now which caused sleepless nights (Jun2021). AE resulted in: Doctor or other healthcare professional office/clinic visit. Treatment received (still have to visit clinic for the itch). The outcome of the events was Not recovered.
Pain at injection site, myalgias, arthralgias that do not respond to NSAIDS & last for up to 2 wks.
Beginning of November, I tested positive for COVID-19. My first symptoms that all a stuffy head. And it felt like a really bad, I was tired with congestion.  I did go to the doctor for Paxlovid. But the in the middle of February I came down with a cold and was tested for FLU, COVID-19 and Strep. All were negative. They couldn?t get anything because it was not bacterial. That night I could barely breathe while resting. I went back and was given a Z Pack and Prednisone and a cough syrup. I?m sure these medications kept this from forming in pneumonia.
6 days post vaccination (12/23/20),  I developed painful supra clavicular and axillary lymph nodes.  On day 7 itching, hive like red area over injection site, left upper arm. I made an appt with PCP as a precaution.   She thought the area over the injection site could be an allergic reaction or wants to monitor for potential cellulitis.    Lymph nodes are possible immune response to vaccine.   Day 8 area slightly larger and more painful area over injection site.   Have sent  message and picture to PCP. Lymph nodes still enlarged and painful.
Patient came in complaining of reaction. Had what appeared to be cellulitis on inner left arm (upper).
Pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at injection site) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE PAIN (Pain at injection site). At the time of the report, VACCINATION SITE PAIN (Pain at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No conominant medications were reported.  Treatment information was not provided.
This spontaneous report was received from a Nurse refers to an unspecified number of an unspecified patients of an unknown age and gender. On an unknown date, an unspecified number of an unspecified patients were vaccinated with improperly stored GARDASIL 9 lot # L011846 (expiry date: 16-JUN-2017) and lot# L036245 (expiry date: 09-FEB-2018) (dosage not reported). Temperature excursion reported was 56 F for 6 hours. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a registered nurse concerning an 18 year old female with high cholesterol and no allergies who in 1998 was vaccinated with a first and second dose of Varivax. Concomitant therapy included Lipitor and Accutane. On 01-MAY-2006, the patient had a negative titer. Unspecified medical attention was sought. At the time of the report, the patient had "not recovered." A product quality complaint was not involved. Additional information has been requested.
unable to lift arm; fear of having stroke, fear of having heart attack; Arm hurt; Dizziness / lightheaded; feels like crap; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt), VACCINATION SITE MOVEMENT IMPAIRMENT (unable to lift arm), DIZZINESS (Dizziness / lightheaded), FEELING ABNORMAL (feels like crap) and FEAR OF DISEASE (fear of having stroke, fear of having heart attack) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     The patient's past medical history included Hypertension since an unknown date.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm hurt), DIZZINESS (Dizziness / lightheaded) and FEELING ABNORMAL (feels like crap). On an unknown date, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (unable to lift arm) and FEAR OF DISEASE (fear of having stroke, fear of having heart attack). At the time of the report, PAIN IN EXTREMITY (Arm hurt), VACCINATION SITE MOVEMENT IMPAIRMENT (unable to lift arm), DIZZINESS (Dizziness / lightheaded), FEELING ABNORMAL (feels like crap) and FEAR OF DISEASE (fear of having stroke, fear of having heart attack) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided
Several hours after vaccination, I developed left arm soreness, which persisted for about 36 hours.  Arm soreness was quite severe on 1/8, as it was painful to even lift the left arm for much of the day.  I also noted, about 5 hours after vaccination, that my jaw felt slightly tense, bilaterally.  On Friday, 1/8, I also experienced headache for the entire day, and I was fatigued for much of the day.   I noted clavicular lymph nodes as well.  About 18-20 hours after vaccination, I developed soreness in my back, and about 24 hours after vaccination, I noted some myalgia in the left leg.  These symptoms were responsive to acetaminophen.  The headache, clavicular lymph nodes, arm soreness, and myalgias were resolved by the time I woke up on 1/9.  Finally, I noted development of an axillary lymph node during the evening of 1/8, about 28 hours after vaccination.  This axillary node persisted until Monday, 1/11.
period 2 weeks early; very heavy period; extreme back pain; bad headache; tired; This is a spontaneous report from a contactable consumer. This 46-year-old-female consumer reported that A 46-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot Number: EW0168), dose 2 via an unspecified route of administration, administered in Arm Left on 20May2021 12:00 (age at the time of vaccination was 46-year-old) as dose 2, single for COVID-19 immunization. Medical history included autoimmune thyroiditis from an unknown date and unknown if ongoing, hypothyroidism from an unknown date and unknown if ongoing, irritable bowel syndrome from an unknown date and unknown if ongoing. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number: EW0167), dose 1 via an unspecified route of administration, administered in Arm Left on 29Apr2021 12:00 PM as dose 1, single for COVID-19 immunization and after first dose, period was late, bad headache for a week, fatigue for a week and just overall not feeling well for a week. Facility type vaccine was Workplace clinic. No known allergies were reported. The patient did not receive any other medication within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. It was reported that after second dose, patient experienced started period 2 weeks early, very heavy period, extreme back pain, bad headache, tired on 20May2021 20:00 but not as bad as after first dose. No treatment was received for all the reported events. Outcome of all the events was reported as not recovered at this time of the report.  No follow-up attempts are possible. No further information is expected.
Severe local redness, swelling & induration at injection site R deltoid.  8cm x 6 1/2cm.
This is a spontaneous report from a contactable Nurse. This report was received via a Pfizer sales representative. A 16-year-old female patient received TRUMENBA (lot number and expiration date were unspecified), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced redness and swelling that measured 3 1/2" in diameter on an unspecified date. The patient also could hardly move her arm on an unspecified date. The events took place after use of the vaccine. The outcome of the events was unknown. No follow-up attempts are possible, information about batch number cannot be obtained.
Crying inconsolably since 3:00PM. Vax was received at 9:30AM. Comvax injection site is hot, red, and swollen.
Patient said that soon after receiving his first COVID shot, he experienced extreme arthralgias and new onset arthritis in his  knees, shoulders and arms. He said he never had this in his life and now struggles to ambulate distances > 100 feet and struggles to lift boxes at work. Today he received the second shot and that evening he experienced nausea, vomiting. and then passed out and was brought to the ED.
On Apr 10, 2021, it was the 2nd dose of the COVID-19 Moderna vaccines. (The 1st dose was on Mar 12, 2021).  Both times were done at the.  No significant symptoms happened after the 1st dose.  However, there were reactions after the 2nd dose.  Right after the 2nd dose, that night and the 2 days after, I had high fevers in the range of 100.4 to 101.5.  I also had significant episodes of chills, i.e. feeling uncontrollably cold and shivering, even though I was having high fevers.  Afterwards the fevers and the chills subsided.  I thought all was OK again, and no big deal.  However, on May 01, 2021; I experienced significant chest pain on the left side of the chest (near the heart area).  I could not figure out what caused the pain as I did not have any heavy physical activities.  I thought I had indigestion, but the heart-burn medicine did not help.  As the chest pain intensified, and my blood pressure climbing up to around 125 / 70 to 127 / 70 (my typical normal blood pressure was about 95 / 65),  I was afraid of having a heart attack, so at around 7 PM, I went to the Urgent Care facility, Patient First, in.  They told me that I should go to a Hospital ER.  So, around 8 PM, I went. There they did a lot of tests, and told me I did not have a heart attack nor blood clots, but I had some bad inflammation of unknown pathology.  They also said my EKG had changes and they were concerned because of that change, but they could not figure out the reason.  The ER doctor ordered and I was given an injection of a strong anti-inflammatory medicine.   After keeping me there until almost 2 AM to 3 AM of the following early morning, they discharged me when the symptoms reduced.  I remembered, about 30 minutes after receiving the injection of the anti-inflammatory medicine, the chest pain got lessened, and my heart pressure went back down to about 115 / 70 (It was 127/70 when I checked into the ER).  All in all, it was a really scary event for me that night.  At first, I did not associate this event with the COVID-19 vaccine.  However, after reading many news articles about the possibility of COVID-19 vaccine-induced heart inflammation, I believed I should report this adverse reaction (chest pain) event, and all other adverse reactions I experienced, to the system. I'd like the scientists beware that the reactions of chest pain could also happen to older (female) adults.