chrisvoncsefalvay/vaers-outcomes huggingface dataset:
it felt like my ovaries were on fire; horrible cramps; Two days later I was on my kitchen floor in pain; Had cyst on my ovaries; monthly cycle has been irregular since. Severe bloating and random periods; Brain fog is huge as well; This is a spontaneous report from a contactable Other HCP. This 37-year-old female Other HCP (patient) reported for self that received second dose of bnt162b2 (BNT162B2, Formulation was Solution for injection, Lot Number EL9265), dose 1 via unspecified route in left Arm on 28Jan2021 16:30 as dose 1, single for COVID-19 immunization (age at time of vaccination 37 years). The patient medical history was none, and concomitant medications were not reported. The patient was not taking other vaccine in four weeks and also did not take other medications in two weeks. The patient did not have COVID prior vaccination and she was COVID tested post vaccination. On 28Jan2021 17:00 The patient experienced felt like her ovaries were on fire and horrible cramps. Two days later she was on her kitchen floor in pain. Went to several doctors and ended up at the gynecologist. Had cyst on her ovaries and went through several test to rule out fibroids. Her monthly cycle had been irregular since. Severe bloating and random periods. Brain fog is huge as well. The patient received treatment included Pap smears, ultrasounds. The patient had an allergy including Iodine, codeine. The outcome of all events was not recovered yet.
started experiencing pins and needles feeling in her hands legs and feet, nothing debilitating; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 08Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PARAESTHESIA (non-serious) with onset 08Mar2021, outcome "not recovered", described as "started experiencing pins and needles feeling in her hands legs and feet, nothing debilitating". Additional information: The patient got the first dose on 08Mar2021, Monday, and later that same day, she started experiencing pins and needles feeling in her hands legs and feet, nothing debilitating. It was reported that it was still going on, so she was wondering if this was a known side effect of the product, or if she needed to go see her doctor.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Two patients (ages 8 years and 11 years) were supossed to receive a bivalent Moderna booster as they were due for a booster. Both patients received a 3rd dose of the Moderna monovalent formulation for ages 6-11 years due to confusion about the phrase "booster dose" on the box. Staff is trying to contact the parent of these patients to assess current condition and determine next steps for vaccination.
-Menstruating at time of ovulation in August 2021 (one-time occurrence) -Increase in menstruation pain since June 2021 (has continued until today)
Site: Pain at Injection Site-Medium, Systemic: Numbness (specify: facial area, extremities)-Severe, Additional Details: Patient describes feeling numbness inhis arm and is unable to grip anything or use his arm after recieving his vaccine.  He has been to a physician and followup has been encouraged.
COVID-19 resulting in inpatient hospitalization" of a vaccinated patient.  Pt received two Moderna vaccines in April but specific dates are not known
Patient age was miscalculated. Administered HPV9 vaccine to an 8 year old, at 2 months prior to 9th birthday.
Pt recvd vax & exp elevated liver function tests; reporting nurse indicated info is 2nd hand; No further details are available;
Pt c/o not feeling well in 30 min waiting area.  Pt taken to Observation area via w/c.  Small emesis. Pt laid on cot with feet up for 20 minutes & stated he was feeling better.  4:25 pm BP 136/92 P 96 Pt left with daughter walking w/o assistance.
significant stiffness; exhaustion; soreness; uncomfortable; made it impossible to do anything; a bit sore location arm and back; a bit sore location arm and back; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 20Mar2021 15:00 (Lot number: EN6206) at the age of 45 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Cystic acne" (unspecified if ongoing). Concomitant medication(s) included: ALDACTONE [SPIRONOLACTONE]; PROBIOTICS. Past drug history included: Codeine, reaction(s): "Drug allergy". The following information was reported: BACK PAIN (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 20Mar2021, outcome "recovered with sequelae" (Mar2021) and all described as "a bit sore location arm and back"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 21Mar2021, outcome "recovered with sequelae" (Mar2021), described as "significant stiffness"; FATIGUE (non-serious) with onset 21Mar2021, outcome "recovered with sequelae" (Mar2021), described as "exhaustion"; PAIN (non-serious) with onset 21Mar2021, outcome "recovered with sequelae" (Mar2021), described as "soreness"; DISCOMFORT (non-serious) with onset 21Mar2021, outcome "recovered with sequelae" (Mar2021), described as "uncomfortable"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 21Mar2021, outcome "recovered with sequelae" (Mar2021), described as "made it impossible to do anything". Therapeutic measures were not taken as a result of back pain, pain in extremity, musculoskeletal stiffness, fatigue, pain, discomfort, loss of personal independence in daily activities.  Additional information: The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The patient was not pregnant at time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The vaccine was administered in Public Health Clinic/Veterans Administration facility.   No follow-up attempts are possible. No further information is expected.
no calls received, no complaints noted from pts. Mother used Tdap instead of Td for 2nd dose.
This spontaneous report was received from a pharmacist via RMPDC (rocky mountain poison and drug center) regarding a 29 year old female patient. The patient's past drug history was unknown. The patient's concurrent condition included pregnancy and the date of her last menstrual period was 14-MAR-2016. The due date of pregnancy was 19-DEC-2016. Concomitant medications included prenatal vitamins. The patient's relevant laboratory data included a positive pregnancy test on 14-MAY-2016. The pharmacist confirmed that the patient should have been immune and had a measles IgG titer, mumps IgG titer, and rubella IgG titer drawn on 28-MAY-2016 however the results were still pending. On 29-MAY-2016, the patient received an extra dose of M-M-R II (lot # L049316, expiry date: 03-DEC-2017) subcutaneously in the left arm during pregnancy. The patient had previously received M-M-R II on unknown dates. The patient had not experienced any adverse reactions to the vaccine thus far. The outcome of the pregnancy was unknown. Additional information had been requested.
Patient came in to the pharmacy to receive second dose of the covid-19 vaccine around 1230pm on 4-2-2021.  She stated that after she left from her first dose her jaw felt slightly weird but nothing more than that and it went away after a short wile.  It was determined to give her the second dose but to monitor her for any reactions/anaphylaxis.  She received the vaccine around 1:00pm from a pharmacy tech, and within 5ish minutes told my tech that her jaw line was tingling and her lips felt swollen.  Pharmacist on duty, took the e-kit and went to check on her.  She seemed to be talking fine and stated she wasn't having a hard time breathing.  Pharmacist made the decision with the patient's consent to call 911 to be on the safe side.  No meds were administered.  Paramedics showed up, evaluated patient, and with the patient's consent, took her to the ER.   The pharmacy followed up with the patient on 4-5-2021 to make sure she was okay.  She said she was doing fine and that on 4-2-2021 her throat started to get prickly when she got to the ER so they administered bendadryl which helped.
Case number PHEH2015US026578, is an initial spontaneous report received from a consumer on 14 Dec 2015. This report refers to a 63 year old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with FLUVIRIN (batch number and expiry: not reported) subcutaneously on 09 Dec 2015. FLUVIRIN was given under skin and not in muscle (administration error). It was reported that health care professional gave two vaccines at the same visit (unspecified). The patient experienced headache, fever, muscle aches, some diarrhea and he was really tired. The outcome of the events headache, fever, muscle aches, some diarrhea and really tired was reported as complete recovery on 09 Dec 2015. The seriousness and causality of the events were not reported.
aches; needed rest; Tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aches), BED REST (needed rest) and FATIGUE (Tired) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced PAIN (aches), BED REST (needed rest) and FATIGUE (Tired). At the time of the report, PAIN (aches), BED REST (needed rest) and FATIGUE (Tired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication not provided. Treatment medication not provided.   This case was linked to MOD-2021-073946 (E2B Linked Report).; Sender's Comments:  MOD-2021-073946:Second dose
I do not have the information for the Vaccine was done on 02/02/2021- Presented chills, running nose, and smizing
Information has been received from a licensed practical nurse concerning a 38 month old female patient with amoxicillin allergy, and no other pertinent medical history, who on 03-MAY-2007 was vaccinated with a dose of VARIVAX (Merck) (lot# not provided) as "part of 1 year shots". There was no concomitant medication. On 10-JUL-2009 the patient developed chickenpox, and that same date the patient was seen at the office. No labs diagnostic studies performed. Symptoms presented as rash and red bumps "all over" along with a low grade fever of 99 F. The patient was recommended to use CALAMINE LOTION, oatmeal bath and BENADRYL. The patient was also advised to use contact precautions and follow-up in one week. On 13-JUL-2009 the patient had several lesions with pus. On 12-AUG-2009, the patient no longer had lesions and she had a cough. This is one of several cases reported by the same source. Follow-up information was received from the licensed practical nurse regarding that the 38 month old female (37lb, 381/2 inch) with amoxicillin allergy and reactive airways disease (RAD), who on 03-MAY-2007 was vaccinated with a dose of VARIVAX (Merck) in the same date also received a dose of MMR II (MSD) and VAQTA (Manufacturer unknown). It was reported that on 13-JUL-2009 the patient presented to the office with chickenpox, healing lesions and afebrile. On 13-JUL-2009 (previously reported as 12-AUG-2009) the patient had recovered. It was noted that on 09-AUG-2007 the patient received a fourth dose of DTaP and the fourth dose of Hib (unspecified carrier). Additional information is not expected.
the patient is currently hospitalized at Hospital. The patient became symptomatic a few days before being teste which he experienced a low grade fever, body aches, loss of taste and smell, loss of appetite, congestion, cough, shortness of breath, headache, and diarrhea. Patient's wife stated the patient has alot of medical conditions which she believes has caused some symptoms and not just covid. Patient has cancer, high cholesterol, and arthritis.
The COVID-19 vaccine administered through Catalent's vaccine administrator between June 25 and July 30 came from the lot number 039K20A. It was discovered that this particular lot was beyond its frozen expiration date by five (5) up to forty (40) days. A case was opened with Moderna (Case #: MOD21-126790).  Please refer to this case number if you would like to contact Moderna directly.  Moderna confirmed that the vaccine doses administered maintained the activity necessary to protect against the COVID-19 virus.  Moderna also confirmed there is no danger to anyone's health from receiving a vaccine past its frozen expiration date.  No adverse reactions were identified.
We are not aware of any adverse events at this time.  Patient only reported his arm being sore similar to other COVID vaccines.  This is to report an error in administration.  The patient was supposed to receive 0.5 mL of the Bivalent Moderna Covid-19 booster.  However, he received 0.5 mL of the original Moderna vaccine (essentially the patient received another primary series dose).
CRAPPY; This spontaneous report received from a patient via a company representative 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, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 10-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-MAR-2021, the subject experienced crappy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of crappy was not reported. This report was non-serious.
3 minutes after the vaccination was given my lower left teeth started throbing in pain followed immediately by lightheadness.  Nurse put oxygen on me and took my blood pressure which was 202/122 recheck was 190/130.  Clonodine 0.1mg was administered  and BP was 179/120. My heart rate was slightly elevated at 101 to 110.  At around 415pm the symptoms began to wax and wain.  My teeth would throb followed by lightheadness then it would subside for about 2 min and it would repeat again. This continued for another 2 hours.  By 7pm it was happened about every 30 min.  Then i felt completely back to normal
Bells Palsy DX on 2/9/2021 Started feeling right sided facial numbness on 2/8/2021 at 4:00 pm. Then noticed slight right eye droop.
Sore arm at injection site; chills and sweats; chest tightness and labored breathing; right eye blurry; seizures: irregular body movements and gait; thought disruption; light sensitivity; headaches; nausea.
I had a high fever of 104F for three days that didn't go down. I had rash on my arm and it was very swollen and red. The arm pain got progressively worse. I had headaches and body aches. I couldn't get out of bed for days. I called the pharmacy and they told me to go to the urgent care.
Pt was admitted to local Hospital 08/26/21 with blood clots in each lung.
Rash across entire back, very itchy and led to scabbing. Finally healed after 1 month.
No additional AE were reported; received improperly stored vaccines; This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 17-MAR-2022, the patient was vaccinated with an improperly stored dose of haemophilus B conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 1 dose, lot #U026217, expiration date: 02-NOV-2023 (strength, exact dose, site and route of administration were not provided) for prophylaxis (Product storage error). On an unknown date, before the administration, vaccine underwent temperature excursion at 34.3 degrees Fahrenheit (F) for 55 minutes. No previous excursions were reported. No adverse events were reported.
Got first pfizer vaccine 3-12-21. Developed SOB after about 10 minutes which resolved with albuterol when got to car.  1/5. to 2 hours later developed dry mouth. Water couldn't produce saliva. Had external cheek paresthesia about 4-5 times on the way home from work that same day. Resolved by time he got home. Over next 2--3 days would get the numbness and tingling on his cheeks. Still had dry mouth. 3-4 days later developed upper/lower lip numbness on the outside for 5-6 episodes. No lip swelling. 5 days after vaccine developed a metallic taste in his mouth. Was still able to eat/smell/taste food. That lasted a day. The following day the metallic taste went just to the right side for a day. Since then occasionally gets a paresthesia around his lip/cheek area.11 days still getting metallic taste sensation for 5-15 minutes at a time
pt recv vax; devel Rubella; f/u from MD stated sx of rash & sl fever; to ER; dx of Otitis; lab eval was neg for Rubella antibody;reporter reported twin patients;
Started feeling a tad weak at first. Then, my hands and feet got really cold. I got in bed to warm them up and was feeling aches, pains, headache, nausea. Then, I threw up around 7:30 pm, which was 10 hours after the injection of the shot. I could not sleep because during the night I had sweats and chills off and on.
7/16/21  -approx 11 pm extreme pain in stomach, fever 101.1-101.3 diarrhea times 4; 7/17/21 -fever continued, diarrhea and abdominal pain continued, tired and sleepy all day; 7/18/21 -normal temp, no diarrhea but gassy and loss of appetite; 7/19/21 -vertigo started in early morning maybe around 3am. Dizziness and unsteadiness on walking and certain head movements.  Do have history if BPPV. Vertigo continues to today 7/22/21 on this reporting; 7/20/21  -itchy skin and sensitive in some places. Mostly back and shoulders. Leading eventually to red blotches and itchiness continuing
28 yo female received second dose of Pfizer COVID-19 vaccine 3/19 at 0933. Around 1130 pt reports numbness and tingling in her mouth and right sided facial drooping. Presents to ED. History of right frontal cavernous malformation, removed in 2013. PMH significant for migraine headaches and vestibular disorder. Evaluated by neurovascular with low suspicion for stroke. Symptoms improving. Received diphenhydramine, ketorolac and prochlorperazine in the CDU. CT brain and angio brain and neck without acute findings. Recommended pt to complete brain MRI with and without contrast to rule out possibility of stroke or underlying lesions to be performed outpatient. Pt discharged later that day with symptoms fully resolved.
Information has been received from a nurse, concerning a patient of unknown age and gender. The patient's medical history, allergies, previously drug reactions, concurrent conditions and concomitant medication were not reported. On an unspecified date, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB), lot number M031574 with expiration date on 11-NOV-2018 (strength, Thimerosal status, anatomical location, dose number and route of administration were not provided), for prophylaxis. The RECOMBIVAX HB was stored at a temperature range of 47 degrees Fahrenheit (°F) to 77 °F (55°F), for a time frame of 30 hours and 43 minutes. There was no previous temperature excursion and the call was because of a data logger. No adverse effects were reported. This is one of several cases received from the same reporter.; Sender's Comments: US-009507513-1808USA002487: US-009507513-1808USA002488: US-009507513-1808USA002489: US-009507513-1808USA002490: US-009507513-1808USA002491:
After receiving my 5th dose of Moderna I contacted COVID-19 infection. My COVID-19 infection started on 01/23/2023 not sure what time of the day. I was sneezing, had a runny nose, fever, chills, fatigue, cough, and body aches. My energy levels became very slow. I tested with a home COVID-19 test on 01/26/2023  which was positive. I did a telehealth with a doctor on the same day and he prescribed me with PAXLOVID for 5 days. After 3 days of finishing the PAXLOVID I had a relapse on 02/02/2023. I had same symptoms except fever. We took over the counter medications such as TYLENOL and other cold medications. After COVID-19 infection my energy level and exercise tolerance is not the same.
angioedema of the face; allergic reaction to the Shingrix vaccine; hives over entire body; pruritus; This case was reported by a other health professional via other manufacturer and described the occurrence of angioedema in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included seafood allergy, iodine allergy and nickel sensitivity.   On an unknown date, the patient received Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced angioedema (serious criteria GSK medically significant), allergic reaction, hives and pruritus. On an unknown date, the outcome of the angioedema, allergic reaction, hives and pruritus were unknown.   It was unknown if the reporter considered the angioedema, allergic reaction, hives and pruritus to be related to Shingrix.  Additional information was provided as follows: The patient had allergies to all seafood, Iodine, Nickel and Acacia. Approximately 24 to 36 hours after receiving Shingrix vaccine, the patient developed angioedema of the face, hives over entire body and pruritus. The reporter if the pfizer covid vaccine could be recommended for the patient. The reporter did not consent to follow up.
This spontaneous report was received from a physician and refers to a patient of unknown age (also reported as "0") and gender. No information about the patient's pertinent medical history, concomitant medications and concurrent conditions was provided. On 10-MAY-2017, the patient was vaccinated with an improperly stored dose of ROTATEQ oral solution, lot # M044399 (dose, and expiry date were not specified) for prophylaxis. The administered dose of ROTATEQ underwent a temperature excursion of 48 Fahrenheit degrees for 30 minutes. There was no Digital Data Logger involved. No previous temperature excursion was reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all available information has been received.; Sender's Comments: US-009507513-1704USA001661:
This child had swelling of the right upper arm, no redness or infection. Advise: warmth and follow up.
This spontaneous report as received from an other health professional refers to patients of unknown age. On an unknown date the patients were vaccinated with an improperly stored dose of GARDASIL 9 for prophylaxis which was stored from 9 Celsius degrees (°C) to 25°C. On an unknown date the patients experienced no adverse event. The outcome of incorrect product storage and no adverse event was unknown. The reporter considered incorrect product storage and no adverse event to be not related to GARDASIL 9.; Sender's Comments: US-009507513-1707USA011790: US-009507513-1707USA011791: US-009507513-1707USA011792; US-009507513-1707USA011793: