chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Slight pressure like ears and eyes; Slight headache but it had become so bad that I never had; Did not feel well; Vision was blur; Hard to open eyes; it is like a pressure; Still I had at back of my head like a pressure little bit; concentration, everything was gone within like so fast; This is a spontaneous report from a Contactable consumer (patient).   A 48-Years-old female consumer received bnt162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL3247), via an unspecified route of administration on 28Jan2021 as an 1ST DOSE, SINGLE for COVID-19 immunization (age a vaccination 48-Years-old). Medical history and concomitant medications of the patient were none. On 28Jan2021 around one hour after vaccination, the patient had slight pressure like ears and eyes, slight headache but it had become so bad that she never had, hard to open eyes; it was like a pressure, did not feel well, vision was blur, concentration, everything was gone within like so fast, Still I had at back of my head like a pressure little bit. Clinical course was provided as follows: She had her first dose and started having some symptoms right like within an hour or so. It was a slight pressure like ears and eyes and little like slight headache but then it had become like at the end of the day, it was so bad that she never had, (intensity was more than before). It was sudden, and she could not keep her eyes open. It was to that point like hard to open her eyes and it was like a pressure. She went back to the site and checked blood pressure, she recorded it was fine, '100.2 and over' (not further clarified), pulse and everything was fine, but she did not feel well. Even she felt like her vision was blur her concentration, everything was gone within like so fast." She did not receive any medication, but she had sat down and was laid on until she felt normal.    Follow-up attempts are completed. No further information is expected.
weakness; muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness) and MYALGIA (muscle aches) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced ASTHENIA (weakness) and MYALGIA (muscle aches). On 27-Feb-2021, ASTHENIA (weakness) and MYALGIA (muscle aches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not reported.  Treatment medication was not reported.    This case was linked to MOD-2021-030607 (Patient Link).
no further ae reported; Temp excursion on 11/22/21; This spontaneous report was received from a nurse referring to a 49 years old, female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.  Temperature excursion occurred on 22-NOV-2021. On 21-DEC-2021, the patient was vaccinated with the improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneously in the left arm (lot U010398, expiration date 01-APR-2023) (strength and dose were not provided) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneously in the right arm (lot T034389, expiration date 08-OCT-2022) (strength and dose were not provided).  The temperature of storage and time frame of the excursion were 6° to 14° Fahrenheit (F) for 10 minutes and 14° to 46° F, for 3 hours respectively.  If a digital data logger was involved was not reported.  No adverse event.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2201USA003515:
Chills and shivering, fever and sweating, headache, extreme fatigue (in bed from 10pm Monday night to 9am Thursday morning), nausea, pain at injection site, red dot and small rash on hand.
It started with a sore throat and the next day head congestion was present. Some coughing and fatigue as well. The next morning I took a home test with a positive outcome. I did a telehealth virtual doctor visit and was prescribed Paxlovid. I started this medication on 5th day. I was feeling symptoms for about 5 days. I was also taking Mucinex D, vitamin D and zinc.
Persistent Tight chest day after vaccination. Uncomfortable but not painful. Occasional elevated heartbeat when under stress but quickly returned to normal when stress gone. Symptoms finally gone today after almost 3 weeks after vaccination. I have still been able to exercise without problems or pain while exercising - the tight chest has been more of a persistent background discomfort, not painful or problematic for exertion.
On January 21, 2021 at the COVID 19 Vaccine Clinic, an orthopedic PA was administering vaccinations during the morning for a four-hour shift, 8 AM to noon. At the end of her shift, she handed off her vaccines to another vaccinator (a RN). The PA had three doses of vaccine drawn up at that time, in syringes, on her desk. When the RN inspected the syringes, she found 0.4mL of vaccine had been drawn into those syringes rather than the required 0.3mL. The RN then alerted the lead APRN, who escalated the situation to the operations manager. The operations manager then contacted the Chief Quality Officer. The concern was that the PA had been vaccinating patients all morning with an inappropriate dose of vaccine, 0.4mL. After thorough internal investigation, we found that the PA drew up 38 vaccine doses and administered 35 of them. Additionally, based on vial usage for the day and total number of vaccines administered, we have concluded that it is highly unlikely that excess vaccine was administered. This was a ?near miss? event and is being reported out of an abundance of caution.
Mentions she thinks she has gained weight recently, called it COVID fat; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Apr2021 13:00 (Lot number: ER8731, Expiration Date: 31Jul2021) at the age of 72 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Blood pressure high" (ongoing), notes: from 6 months. Family history included: "MS" (unspecified if ongoing), notes: Her daughter has MS. Concomitant medication(s) included: AMLODIPINE taken for blood pressure measurement (ongoing). The following information was reported: WEIGHT INCREASED (non-serious), outcome "unknown", described as "Mentions she thinks she has gained weight recently, called it COVID fat". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.
Pain at injection site, continued for 4 days. Fatigue, headache, shivering, fever, all continue for 2 days.
4 year old MALE patient with preDM, CKD3, HTN,  Anemia, B12 def, Depression and PTSD who noted bruising after 3/11 Covid  vaccination. This was the only new medication exposure he can recall. Notes that  2 days after this vaccination (first shot) he started having easy bruising on  his arm and spotted bleeding on his lower extremities. He noted blood blisters  in his mouth. He was treated with dexamethasone, IVIG and infusions and discharged (admission 3/23-25). He was admitted again on 4/12-4/15 with thrombocytopenia, thought to have ITP by hematology consult service. He was again treated with dexamethasone and IVIG.  He is now admitted for a 3rd time with same issue. Note: vaccine was not given at this site. Do not have lot or route info
Patient has redness, swelling that is warm to touch at location of injection that has been getting larger. Currently measuring at 6cm/5cm. Has been taking Benadryl but has not noticed improvement.
This incident was likely a documentation error. During clinic, the vaccinator documented in database that the patient received Moderna for 2nd dose, even though previous records confirmed that the pt received Pfizer for 1st dose. However, pt confirmed that she received a blue sheet of paper (which in our clinic workflow means Pfizer dose) and that her CDC Immunization Card is labeled as Pfizer for 2nd dose. Vaccinator also confirmed that she only provided Pfizer immunizations for the entire day, and that she is not comfortable/experienced with using a tablet. Thus, it is highly likely that this was purely a documentation error and the patient correctly received the Pfizer vaccine for both doses.
No additional adverse effect reported; expired M-M-R II was inadvertently administered on 11/2/2020; This spontaneous report as received from an office manager refers to a patient of unknown age and gender. Pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 02-NOV-2020, the patient was inadvertently vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot number: S013711, expiration date: 01-NOV-2020, dose and route of administration were not provided). No additional adverse effect was reported.  Lot number S013711 is an invalid lot number for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II). Lot number S013711 is a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD).
Nerve pain in two molars (upper and lower) on left side.   Earlier symptoms included pain at injection site, soreness of arm, headaches, and tiredness.
Arm pain at injection site, started on 11/23/2021 and is still somewhat sore on 11/25/2021.   Flatulence - started 11/23/2021 at about 1PM, continued 11/23/2021, and still noticable on 11/23/2021, thought it is subsiding.
Intermittent sharp pain, dizziness and lightheadedness. Patient reports anxiety, left-sided chest pain (2-6/10) that comes and goes. Mild SOB. No signs of heart attack. BP 118/73, HR - 85, respiratory rate 20.
Information has been received from the mother of a 24 year old female with irritable bowel syndrome and food allergies to 28 different foods, including yeast and corn who on 10/16/06 was vaccinated with HPV Vaccine. Concomitant therapy included Hormonal contraceptives (unspecified) and dermotologic (unspecified). On 10/16/06 the pt experienced nausea, diarrhea, aches, and vomiting which continued for three days without changes. On 10/19/06, it was reported that the pts irritable bowel syndrome was also triggered by the above events. On 10/19/06 the pt underwent a blood test (usually very well tolerated), however following the blood test on 10/19/06, the pt passed out and vomited, Unspecified medical attention was sought. The pts mother stated that she would be contacting her daughters physician with the listed allergies. At the time of this report, the pt was recovering from the events. Additional information is not expected.
This spontaneous report was received from a registered nurse and refers to an unknown number of patients of unknown age and gender. There was no information about the patients' concomitant therapies, medical histories and drug reactions or allergies provided. On unknown dates, from 01-FEB-2017 to 28-FEB-2017, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot# M028323, expiration date: 26-SEP-2018; lot# M017983, expiration date: 30-MAY-2018; lot# M041212, expiration date: 21-JUN-2019; lot# M041990, expiration date: 28-JUN-2019 (dose and route of administration were not provided). There were no adverse events. Administered doses of vaccines were stored in temperature between 47 degrees Fahrenheit and 77 degrees Fahrenheit for 2 hours. Digital Data logger was used to capture temperature excursions. There were no previous temperature excursions. No Product Quality Complaint (PQC) was involved. The nurse stated that the reason for temperature excursion was the refrigerator needing service. It was also added that there were no other temperature excursions once the service was completed. Reporter also stated that she would call back with the information regarding patients who received improperly stored vaccines. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA007278: US-009507513-1705USA007279: US-009507513-1703USA005900.
Pt presented w/SOB, cough, dizziness, & diaphoresis. Given diphenhydramine 50mg PO onsite.
This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender with inflammatory bowel disease. Allergies were not reported. On an unspecified date in December 2014, the patient was vaccinated with a dose of PNEUMOVAX 23, (strength, dose and route were not reported), (lot # K009809, expiration date: 16-MAY-2015) in an unspecified arm. Other suspect and concomitant therapies were not reported. On an unspecified date in December 2014, the patient developed redness, tenderness and pain that radiated down the arm from the injection site. The patient sought medical attention and was seen for the physician the following day (unspecified date) who determined the symptoms to be a cellulitis and prescribed an unspecified antibiotic. Lab diagnostics studies were not performed. A lot check was being requested for this adverse event. The outcome of cellulitis was unkonwn. The relatedness between cellulitis and therpay with PNEUMOVAX 23 was not reported. Additional information has been requested.
Delayed hypersensitivity reaction at vaccine site (redness, warmth, mild swelling, itching)
Itching; Redness; Rash on left arm/also on back just about the waist/bumps; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching), ERYTHEMA (Redness) and RASH (Rash on left arm/also on back just about the waist/bumps) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 13-Feb-2021, the patient experienced PRURITUS (Itching), ERYTHEMA (Redness) and RASH (Rash on left arm/also on back just about the waist/bumps). At the time of the report, PRURITUS (Itching) had resolved, ERYTHEMA (Redness) was resolving and RASH (Rash on left arm/also on back just about the waist/bumps) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        Concomitant product use was not provided by the reporter  No treatment information was provided.
A 35 year old female experienced hives, fever and injection site redness and warmth on 12/24/00 following RabAvert vaccination for post-exposure prophylaxis. The pt received post-exposure RabAvert because she was caring for a sick kitten who was attacked by a raccoon. She received her 1st RabAvert vaccine on 12/17/00 and the 2nd vaccine on 12/20/00 with no adverse events experienced. After the 3rd vaccine was given on 12/24/00 (lot 273011), the pt developed hives from the mid-chest down to her feet which were raised, red ant itchy. She also had a fever and experienced redness and warmth at the site of the injection on her arm. The pt, an RN, treated herself with Benadryl (dose unknown) and the hives were resolved. After the 4th RabAvert vaccine on 12/31/00 (lot 273011), the pt again developed hives from the mid-chest down to her feet (raised, red and itchy), but the intensity was less than after the 3rd dose. She again treated herself with Benadryl (dose unknown) and the problem was resolved. (She did not pre-medicate herself with Benadryl prior to the 4th vaccine). The pt also experienced redness and warmth at the site of the injection on her arm after the 4th dose. The pt has no known medical conditions, allergies or long-term medications. The pt's son also received post-exposure RabAvert vaccinations with lot 273011, but he had not experienced any adverse events.
On the evening of March 6, 2021, patient tried to exercise (consistent with regular routine) and couldn't do more than 15 minutes. He was very winded. On March 7, we skipped exercise. On March 8, patient tried to do simple stretching exercise, and couldn't do it. He got winded and shaky. On March 9, he was seen at an urgent care where he was told he had an inverted T wave on his EKG and a very fast heart rate (125 resting pulse). He was told to not exercise and to make an appointment with a cardiologist. On March 9, I called the urgent care clinic to ask questions about monitoring his blood pressure and when to seek more medical care. I spoke with Dr, who prescribed Atenolol. Around 4:30 pm on
unknown Narrative:  Moderna COVID-19 Vaccine EUA Moderna COVID vaccine was administered to individual (volunteer) under 18 years of age earlier this year, but error just recently discovered. No information regarding if/what adverse events occurred is included in available report or if any medications were needed to treat an ADR, however the individual received the initial dose of Moderate COVID vaccine on 3/4/21 (separate AE entered) and was interested in receiving a booster (which, to my knowledge, was not administered). Unknown if received other vaccines recently (aside from Moderna COVID vaccine earlier that month), if had history of ADRs to other vaccines, past medical history.
I tested positive for COVID-19 on 12/17/22. I started having symptoms on 12/16/22. I had congestion, sore throat, cough, a bad headache, and body aches. I went to urgent care and was prescribed 5 days' worth of PAXLOVID, benzonatate, and albuterol. I felt terrible until 12/19/22 and I started to feel a lot better. I still have some congestion, but other than that I feel pretty good.
Sunday  arm very sore, painful red pimple looking bumps on left arm and on neck. Mon sore throat and chills. Tue sore throat chills bone aches, Wed and today sore throat  was seen on Tue by PCP and Got Covid Test.
Intense pain in my right jaw and upper and lower mouth (right side). It feels like I have numerous abscessed teeth but when I bite down, my teethe don?t hurt so I know it isn?t a tooth problem. The pain was so intense at night that I couldn?t sleep until I took 800mg of ibuprofen. The next morning, the pain has lessened but was still strong enough that I had to take ibprofen again.
I started to feel discomfort in my left cheek 1 Nov 2021.  On the morning of 2 Nov 2021, I woke up to the left side of my face swollen and a dark mark under my eye from the swelling.  My face was sore.  It felt like the filler in my cheeks had moved around in my face.  After a few days, the discomfort abated.  7 Nov 2021, on the right side of my face, namely my cheek area, I began feeling discomfort.  Today, 8 Nov 2021 the discomfort is worse.  Painful to the touch.  Again, it feels like the filler in my cheeks is moving around.  And again it is painful and swollen at the highest point of my cheek.  Unable to get ahold of the physician that I use for botox and injectibles, I began to google.  Then in dawned on me that all of this started after I received my booster shot of the Pfizer Covid vaccination.  So I googled COVID shot, face swelling, filler.  I found that it was an adverse reaction reported with the Moderna Covid vaccine.  So I added "Pfizer" to the search.  COVID shot, face swelling, filler.  I found a study and report that the discussed the rare adverse reaction of dermal fillers and the Pfizer/BioNTech COVID vaccine.  I received dermal fillers in my cheeks in May 2021.  This was after my first 2 COVID vaccinations.  Because it definitely feels like there is something going on with the fillers in my face.  It's weird, uncomfortable and scary.  I hope by the end of this week the right side of my face will feel better and I won't experience any further adverse reaction.  I will try to see the doctor as soon as possible (they won't answer their phone!!!!)
About 10 to 15 minutes following vaccine administration, patient started to develop diffuse urticaria, SOB, tachypnea, and wheezing. Considering symptoms and rapid onset, IM epinephrine (0.01mg/kg) was given. Patient seemed to have immediate improvement of respiratory distress. Patient was brought over the ED by provider and sign out was given to ED attending physician. Patient was seen immediately in ED.
minutes after receiving vaccine the seated patient complained of dizziness and nausea.  pt was also in cold sweats and proceeded to vomit
Yearly blood work on physical exam showed a decrease in platelet count following the COVID 19 MODERNA VACCINE. Platelet count decreased from 209 in March 2020 to 143 in March 2021 following vaccination. Platelet count February 1 2018= 219 Platelet count in March 13 2019 = 229 Platelet count March  9 2020= 203 Platelet count March 29 2021= 143  The platelet count is now continuously low. Levels have dropped even further to 100 in September 2021.
STERILE WATER FOR INJECTION WAS MIXED IN AS DILUENT.  NO ADVERSE REACTION REPORTED BACK TO PHARMACY AT THE TIME OF THIS REPORT
From three weeks to a month after the second dose, the swelling of the wrists and pain and loss of strength in the arms began. In turn, menstruation turned into a painful one with a huge amount of clots, excessive bleeding that causes dizziness. The pain in the bones and the swelling of the joints along with the menstrual situation continues to this day 11 months after the second dose and affects my performance and daily activities.
Migraine-came around Friday about 6:15 pm, slowly went away during 3 days Heart Palpitations-Saturday night, lasted for 2 days Nausea-duration of 3 days starting Saturday Dizziness-Saturday, all day and Sunday in the morning
Patient complains of upper back pain, states she was picking up her 2 year old daughter and heard a "pop." Patient also had fatigue and joint pain starting 2 days after shot was administered. Fatigue has resolved but joint pain has persisted. Patient reports fingers, knees and left heel"ache". Patient states her joints feel itchy.
This spontaneous case was reported by a consumer and describes the occurrence of THYROIDITIS (thyroiditis), COUGH (cough), DYSPNOEA (shortness of breath), ASTHENIA (weakness) and ABDOMINAL PAIN UPPER (Epigastric pain) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was reported. On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THYROIDITIS (thyroiditis), COUGH (cough), DYSPNOEA (shortness of breath), ASTHENIA (weakness), ABDOMINAL PAIN UPPER (Epigastric pain), PYREXIA (fever (100°F average)), ARTHRALGIA (joint pain), MYALGIA (muscle aches), HEADACHE (headache (occipital region)), FATIGUE (fatigue) and PRODUCT DOSE OMISSION ISSUE (Didn't get the 2nd dose/got the 1st dose back in January). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; IBUPROFEN at an unspecified dose and frequency and OMEPRAZOLE at an unspecified dose and frequency. At the time of the report, THYROIDITIS (thyroiditis), COUGH (cough), DYSPNOEA (shortness of breath), ASTHENIA (weakness), ABDOMINAL PAIN UPPER (Epigastric pain), PYREXIA (fever (100°F average)), ARTHRALGIA (joint pain), MYALGIA (muscle aches), HEADACHE (headache (occipital region)) and FATIGUE (fatigue) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Didn't get the 2nd dose/got the 1st dose back in January) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: increased (High) 100 degree Fahrenheit average. On an unknown date, Heart rate: increased (High) 115 bpm average heart rate. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. The patient mentioned taking birth control as concomitants. The patient went to the hospital several times and received medication there.