chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Caller said something about side effects but nothing in particular was mentioned; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Jul-2021 and was forwarded to Moderna on 29-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (caller said something about side effects but nothing in particular was mentioned) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (caller said something about side effects but nothing in particular was mentioned). At the time of the report, VACCINATION COMPLICATION (caller said something about side effects but nothing in particular was mentioned) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant treatment was provided. No treatment medication was provided. Very limited information was available for adverse event.
This spontaneous report as received from a medical assistant refers to a patient of unknown demographics. The concurrent condition and medical history was not reported. Approximately in December 2014 (reported as 5 or 6 months ago) the patient was vaccinated with GARDASIL dose 1 (route unspecified). Other suspect therapy included DEPO-PROVERA. The concomitant medications were not reported. It was reported that the patient went to the office on 11-JUN-2015 (reported as today) to receive the second dose of GARDASIL. Vaccine however, the patient was inadvertently administered with a dose of DEPO-PROVERA instead of GARDASIL. Vaccine on an unspecified date. It was also reported that the patient was receiving the second dose of GARDASIL. Vaccine late. No adverse event was reported. Additional information is not expected.
Pain 10-14-09 L upper arm woke this am with redness, swelling 5-6" area, fatigue seen 10-15-09. Tx HYDROXYZINE 10-20-09 only slight itch almost completely resolved.
Second dose was scheduled for 22May2021. Patient missed the second dose; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Jun-2021 and was forwarded to Moderna on 25-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Second dose was scheduled for 22May2021. Patient missed the second dose) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Second dose was scheduled for 22May2021. Patient missed the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Second dose was scheduled for 22May2021. Patient missed the second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.     No concomitant medications were reported. No treatment medications were reported.
Hives; Diarrhea; Headache; Fever; Unevaluable event; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives), DIARRHOEA (Diarrhea), HEADACHE (Headache), PYREXIA (Fever) and UNEVALUABLE EVENT (Unevaluable event) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease and Ulcerative colitis.    Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.   On 22-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. In 2021, the patient experienced HEADACHE (Headache), PYREXIA (Fever) and UNEVALUABLE EVENT (Unevaluable event). On an unknown date, the patient experienced URTICARIA (Hives) and DIARRHOEA (Diarrhea). At the time of the report, URTICARIA (Hives) had not resolved, DIARRHOEA (Diarrhea) outcome was unknown and HEADACHE (Headache), PYREXIA (Fever) and UNEVALUABLE EVENT (Unevaluable event) had resolved.            There was no reported medical history. Daily dose for HUMIRA was reported as Citrate Free. For HUMIRA, the reporter causality for the events of Hives, Diarrahea, Headache, Fever and Congestion was not provided. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. No treatment medicine was reported.   Reporter did not allow further contact
Patient presented to the ED 5/20/2021 and was subsequently hospitalized for partial intestinal obstruction within 6 weeks of receiving COVID vaccination. Patient also presented to the ED 6/7/2021 for upper abdominal pain and was subsequently hospitalized.
Headache; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer or other non hcp, reported for a female patient (wife) of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced headache. Reporter considered the event as non-serious. The outcome of the event was unknown on an unspecified date.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Patient was admitted on 01/14/22 because of shortness of breath cough and fatigue  she was lightheaded while ambulating to the bathroom prompted her to come to the emergency department.  She does have a sinus congestion and pressure headache which is a chronic issue.  She denies any high-grade fever but feeling cold. She tested positive for COVID. She was placed on a dexamethasone, vitamin-C, vitamin-D and zinc supplements. Also started on Cipro for 5 days for UTI. She was placed on a 2 L of oxygen via nasal cannula was successfully weaned off and she did quite well.  She was ambulatory independently.  She was stable for discharge after 2 days at the hospital.  On 05/4/22 Patient was admitted because of sinus pressure and shortness of breath for last 1 week.   She went for evaluation and from that she was sent to the emergency department she was found hypoxic 88%.  Patient denies any anginal-type chest discomfort or palpitation.  She does have a cough with white phlegm. Respiratory protocol was started. IV dexamethasone 6 mg daily changed over to oral at the time of the discharge. vitamin C vitamin D and zinc.. Was started on IV Rocephin and Zithromax. Patient completed 5 days of the Zithromax and doing well off antibiotics. Patient is doing quite well have a no significant shortness of breath.  Her oxygen saturation was normal on room air.  Patient have a reactive airway disease component because of a viral bronchitis she may continue to use albuterol as needed for wheezing.  Her hospital stay was 4 days long.
-Breakthrough Menstral 1/2 month early while on controled progesterone blocker ( contraceptive ).  Very heavy and has lasted one week already. -Dull headache off/on like a vice clamp still a week later -Vertigo & confusion still a week later
About 20 min after receiving the vaccine, the bottom half of my face became numb/tingly, along with tightness in my throat. I went back in the store to advise the pharmacist and she gave me Benadryl.
About 30 hours after receiving the vaccine, I began to feel nauseous and weak. About 10 minutes after that, I was unable to sit at a table and had to lie flat on the floor. About 20 minutes after that, I developed shaking and chills (despite wearing a heavy sweater and being wrapped in a warm blanket on a warm day). This lasted for about two hours. I may have had a fever but did not check. After that, I felt exhausted and weak, but no longer had chills. I had to miss a day of work. By early evening I was feeling better, though still tired. The next morning I was much better. I think having a reaction so severe that I missed work, while not causing disability or death, is significant. These were not "mild" events.
Patient called me today complaining of raised red/purple area around injection site, fever of 101 degrees F, and an itching all over her body. She received the FLUZONE intradermal injection.
Patient came into pharmacy complaining of nerve pain under injection site since vaccine was given. Second dose of series was given with no complications.
Rash started on back & spread up side of body as well, treated with oral Benadryl & seems to be improving.
Left upper arm diameter 8 3/4 inches vs 8 inches on Right upper arm. 6.5 inches diameter of erythema, warm to touch, firm. Prescribed Orapred 15/5 and Keflex 250/5.
swelling at injection site; injection site warmth; low grade fever; tenderness in the arm where the vaccination was; redness increased at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (redness increased at injection site), INJECTION SITE SWELLING (swelling at injection site), INJECTION SITE WARMTH (injection site warmth), PYREXIA (low grade fever) and INJECTION SITE PAIN (tenderness in the arm where the vaccination was) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concomitant products included OMEPRAZOLE for an unknown indication.   On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (redness increased at injection site). On an unknown date, the patient experienced INJECTION SITE SWELLING (swelling at injection site), INJECTION SITE WARMTH (injection site warmth), PYREXIA (low grade fever) and INJECTION SITE PAIN (tenderness in the arm where the vaccination was). At the time of the report, INJECTION SITE ERYTHEMA (redness increased at injection site), INJECTION SITE SWELLING (swelling at injection site), INJECTION SITE WARMTH (injection site warmth), PYREXIA (low grade fever) and INJECTION SITE PAIN (tenderness in the arm where the vaccination was) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Treatment information included putting ice pack.
Shortly after second shot on 4/27/21, I took notice that I was feeling joint pain in my fingers, Arthralgia or Arthritis. Maybe started after first shot.  Sometime shortly after second shot really noticed pain and I started experiencing trigger finger locking at night in my right hand middle and ring fingers.  NEVER had these symptoms or trigger finger experience prior to the vaccination.  Felt the pain and occasional clicking in those finger joints and soon thereafter started having trigger finger locking that wakes me up at night.  Never heard of trigger finger before and have since bought a brace to wear at night.
The arm was sore a little bit; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the right arm on 08Apr2021 at 09:00 (at the age of 36-year-old), as a single dose for COVID-19 immunisation. Medical history included bipolar disorder, anxiety attack and COVID-19. The patient did not have a history of allergies to food, medications, or other products. Concomitant medications included aripiprazole 20 milligrams (MANUFACTURER UNKNOWN) and sertraline unknown dose in mg (MANUFACTURER UNKNOWN) for an unknown indication and from an unknown date. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 08Apr2021 at 09:00, the patient experienced arm was sore a little bit. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown whether therapeutic measures were taken as a result of the event. The clinical outcome of the event arm was sore a little bit was recovering at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
I had a severe headache; bilateral legs felt heavy; intermittent chest pain for 2 weeks; lump at injection site; This is a spontaneous report from a contactable other hcp (patient). A 51-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FC3183), via an unspecified route of administration, administered in Arm Right on 17Sep2021 17:30 (at the age of 51-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included Stage 2A cancer left breast, in remission; Lymphedema left axilla, arm, and scapula. Concomitant medication(s) included exemestane 25 mg taken for an unspecified indication, start and stop date were not reported; vitamin d 2,000 IU (vitamin d NOS) taken for an unspecified indication, start and stop date were not reported; folic acid taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccine in four weeks and other medications in two weeks included Exemestane 25 mg; Vitamin D 2,000 IU; Folic Acid. The patient experienced a severe headache, bilateral legs felt heavy, intermittent chest pain for 2 weeks, lump at injection site on an unspecified date. Patient did not have covid prior vaccination and covid was tested post vaccination. The patient underwent lab tests and procedures which included sars-cov-2 test (Binax) negative on 01Nov2021 Nasal Swab. The outcome of all events was unknown.  Follow-up attempts are completed. No further information is expected.
About 7 days after vaccine given in left arm, left arm had two large round, red, warm areas appear. after about 2-3 days rash spread to entire upper left arm from elbow to neck.  rash became more spotted and severe itching began.  vaccine was given on 2/3/21, rash appeared on 2/10/21.  today is 2/18/21 and entire arm is covered with dark red spots that still has severe itching.  Have used Benadryl pills and hydrocortisone crème without relief.  today will try caladryl lotion.
Extreme exhaustion to the point I had to be helped inside my home by my family as well as neck and back pain.  My neck and back are still not great today but much better than they were. I am wondering if the nurse hit a nerve maybe?
hearing loss; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. In 2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated for zoster-related hearing loss. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event hearing loss was not recovered. The causality assessment was considered as related by the lawyer.  Upon internal review, hearing loss was determined to be medically significant.
Patient has had a fever of 102.8 since this afternoon, has been treating with ibuprofen. Counseled to continue pain medication and see a physician if it continues or gets any worse.
Patient experiencing arm pain both during movement and at rest, worsening during movement until raising arm to shulder height, at which point pain becomes unbearable.  Patient has tried acetaminophen and ice, without relief.  Patient expereincing some level of relief with 400mg of ibuprofen every 6 to 8 hours, but not complete relief.  Patient has been refered to primary care physician for evaluation.
Daily Migraines after the first shot. Second dose, Hives for 5 days, migraines daily for more than a month, chest became tight and hard to breath. Pink eye with discharge for three days. Eyes were glossy for a week after. Patient did not have clarity thinking.
A non-serious spontaneous report of coughing has been received from a physician concerning a 17-year-old male, subsequent to H1N1, Intranasal. The patient has a past medical history of asthma and has not had any problem with his asthma for years. On 29-Oct-2009, the patient received H1N1, Intranasal for an unknown indication. On 29-Oct-2009, night, the patient experienced a lot of coughing which lasted up to the morning of 30-Oct-2009. The outcome of the event was resolved.
No Additional AE's reported; She reported that GARD ASIL 9 and V AQT A were administered to a patient today that had undergone temperature excursion; This spontaneous report was received from a medical assistant referring to a 15-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported.   On 29-SEP-2021, the patient was vaccinated with hepatitis A vaccine, inactivated (VAQTA) (lot number U003464 has been verified to be valid, expiration date reported and established as 02-MAY-2022) and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot number T039467 has been verified to be valid, expiration date reported and established as 20-MAY-2023) (doses, routes of administration, anatomical sites of vaccination, dose numbers and vaccine schemes were not reported). Both vaccines were administered as prophylaxis.   It was reported that the vaccines undergone a temperature excursion of 1.3 degrees Celsius (C) during a time frame of 15 hours and 43 minutes (product storage error). There was no previous temperature excursion, and no additional adverse events were reported (no adverse event).
She woke August 24, the morning after her YF shot, drenched and achy. Assumed it would go away but a few days later had back pain "It locked" and then developed problems in her knees, first one and then the other. Continued to have various problems with her knees and started to feel very tired,"Drained" and both knees swelled. She tried OTC meds and cold packs, etc, as she is a runner and treats herself frequently for such things and didn't think it would last. She just muscled through because she has children and is very busy, but realized today that it all started after YF shot almost 6 weeks ago. Knee swelling and other sx are a little better and not gone. Has not sought any medical help.
itchy; light raxh appeared slowly on the top of both forearms; some bumps on chest/tops of his forearms had bumps; This spontaneous case was reported by a consumer and describes the occurrence of PAPULE (some bumps on chest/tops of his forearms had bumps), PRURITUS (itchy) and RASH (light raxh appeared slowly on the top of both forearms) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19. Concurrent medical conditions included Drug allergy (Anti Fungal Creams).    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced PAPULE (some bumps on chest/tops of his forearms had bumps) and RASH (light raxh appeared slowly on the top of both forearms). On 10-Mar-2021, the patient experienced PRURITUS (itchy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itchy, at an unspecified dose and frequency. On 14-Mar-2021, PAPULE (some bumps on chest/tops of his forearms had bumps) and RASH (light raxh appeared slowly on the top of both forearms) had resolved. At the time of the report, PRURITUS (itchy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jun-2020, SARS-CoV-2 test: positive (Positive) PCR(Twice).     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided  Patient got second dose on 19-MAR-2021 on right arm, batch number was 044A21A.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Reporter address, race, medical history, lab data were added. Second dose information, treatment medication, new event were added, outcome of the events were updated to resolved. Event start date and stop updated
Continuous severe high-pitch ringing in both ears and head pressure with intermittent headaches.
Customer received vaccine and shortly began to feel dizzy, lighted-headed, and fainted while seated.  She became responsive and was sweating stating she did not feel well.  Customer complained of feeling nauseated, hands were cramping and difficult to move. Finger tips were tingling.  She sat in our waiting area and was observed for over 30 minutes. She began to feel better after 15-30 minutes.
Besides feeling foggy - since the day after the first shot, I have had serious facial spasms on the right side of my face, lasting day and night, and numbness in my face. They increased in amount each day with the most the entire 2nd week and started to fade the third week. I 100% believe this is from the vaccine and because of it I am afraid of getting the second shot in fear of full loss of my facial muscles.
On 10/29/2021, the employee reported to her supervisor that she began having a large knot under her left armpit on 10/6/2021.  She was seen by the Employee Health physician that day.  She was prescribed a Medrol dose pack for localized inflammation and was scheduled for 11/2 to have a vascular venous ultrasound of the left arm due to pain and swelling of the left proximal upper limb to rule out a DVT.  The results showed an acute DVT within the left brachial vein.  During the ultrasound, she began having chest pain and was sent to the ER for evaluation.  Several tests were performed, including  a CT angiogram to rule out a pulmonary embolism.  The CT was negative for a PE.  The employee was discharged with a new prescription for Eliquis and referred to a specialist clinic.