chrisvoncsefalvay/vaers-outcomes huggingface dataset:
started her Periods again on July 13th, 2021 to Still going on which is not normal at all; weakness; sick; Patient has not had a menstrual period since her second Moderna Covid-19 Vaccine; Sore Throat; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HEAVY MENSTRUAL BLEEDING (started her Periods again on July 13th, 2021 to Still going on which is not normal at all) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product MEDROXYPROGESTERONE for Menses lack of.    No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-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 MEDROXYPROGESTERONE (unknown route) 10 milligram. On 15-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (Sore Throat) and PYREXIA (Fever). In May 2021, the patient experienced AMENORRHOEA (Patient has not had a menstrual period since her second Moderna Covid-19 Vaccine). On 13-Jul-2021, the patient experienced HEAVY MENSTRUAL BLEEDING (started her Periods again on July 13th, 2021 to Still going on which is not normal at all) (seriousness criterion hospitalization). On an unknown date, the patient experienced ASTHENIA (weakness) and ILLNESS (sick). The patient was hospitalized on 07-Jul-2021 due to HEAVY MENSTRUAL BLEEDING. On 16-Apr-2021, OROPHARYNGEAL PAIN (Sore Throat) and PYREXIA (Fever) had resolved. At the time of the report, HEAVY MENSTRUAL BLEEDING (started her Periods again on July 13th, 2021 to Still going on which is not normal at all) had not resolved and AMENORRHOEA (Patient has not had a menstrual period since her second Moderna Covid-19 Vaccine), ASTHENIA (weakness) and ILLNESS (sick) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Company Comment   Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded   Most recent FOLLOW-UP information incorporated above includes: On 24-Jul-2021: Follow up received on 24 Jul 2021. Patient race added and additional events included.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
onset started as itchy around armpits around 10:15pm.  Then hands, eyes and feet started to itch.  Then feet and fingers started swelling, and about five minutes after swelling started, he states he was swollen all over.  Nose, ears, eyes were all swollen. He states that after the swelling he started developing hives all over and redness all over. About 30 minutes later he became short of breath and went to the ER at around 1145 pm.
Not sure EXACT time of onset - above is an approximation.  One day (w/in 24hrs of injection) after injection, child broke out in hives all over his trunk.  Next day (2 days after injection) hives had spread up neck to face; down legs and around injection site; and on arms. Doctor was called at w/in an hour of parents noticing the hives on Wednesday, Aug. 24th.  Doctor advised liquid Benadryl 3x in the next 24hr period which parents complied to.  Child complained of extreme itchiness with the hives with little relief from the Benadryl.
AT APPROXIMATELY 12:03 PM PATIENT FELT DIZZINESS AND SWELLING IN BOTH HANDS.  PATIENT WAS ABLE TO LAY DOWN AND BLOOD PRESSURE AND PULSE WAS CHECKED.  PATIENT ALSO RECEIVED DIPHENHYDRAMINE 25 MG AND PREDNISONE 10 MG.  AT 12;30 PM PATIENT WAS RE-EVALUATED AND SWELLING AND DIZZINESS HAD RESOLVED AND PATIENT WAS ABLE TO LEAVE HOME.
Shoulder is hard; Shoulder is red; Shoulder is swollen with a big knot; Shoulder is very tender; Coughing all night long; Headache; This spontaneous case was reported by a patient and describes the occurrence of INDURATION (Shoulder is hard), ERYTHEMA (Shoulder is red), SWELLING (Shoulder is swollen with a big knot), TENDERNESS (Shoulder is very tender) and COUGH (Coughing all night long) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INDURATION (Shoulder is hard), ERYTHEMA (Shoulder is red), SWELLING (Shoulder is swollen with a big knot), TENDERNESS (Shoulder is very tender), COUGH (Coughing all night long) and HEADACHE (Headache). At the time of the report, INDURATION (Shoulder is hard), ERYTHEMA (Shoulder is red), SWELLING (Shoulder is swollen with a big knot), TENDERNESS (Shoulder is very tender) and HEADACHE (Headache) outcome was unknown and COUGH (Coughing all night long) had resolved.            No relevant concomitant product use was reported.  Treatment details included tylenol, Ibuprofen.   This case was linked to US-MODERNATX, INC.-MOD-2021-078383 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-078383:First dose case
Severe arm and shoulder pain x 5days( unable to lift arms), but continued discomfort for approx. 10 - 14 days.  Recieves flu every year first time with this reaction.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 23-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The date of refrigeration was reported as 7-May-2021 Concomitant medication was not provided. Treatment information was not provided.
Temperature of 101.7 initially,  tremors,  headache,  nausea, dizziness, diarrhea, extreme lethargy. Lasting for 48 hours.
pain in her  left arm; hardly can move her left arm; mobility decreased; weekness in arms; sleep difficult; pain in left arm at site of where shot was given; tingling; numbness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in her  left arm), LIMB DISCOMFORT (hardly can move her left arm), PARAESTHESIA (tingling), HYPOAESTHESIA (numbness) and MOBILITY DECREASED (mobility decreased) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sleep apnea. Concomitant products included LEVOTHYROXINE, ACETYLSALICYLIC ACID (ASPIRINE), METFORMIN, LOSARTAN, AMLODIPINE, CALCIUM, ERGOCALCIFEROL (OSCAL 250+D), HYDROCHLOROTHIAZIDE, SALBUTAMOL (ALBUTEROL HFA) and MULTIVITAMIN & MINERAL for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced PARAESTHESIA (tingling), HYPOAESTHESIA (numbness) and VACCINATION SITE PAIN (pain in left arm at site of where shot was given). On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in her  left arm), LIMB DISCOMFORT (hardly can move her left arm), MOBILITY DECREASED (mobility decreased), MUSCULAR WEAKNESS (weekness in arms) and INSOMNIA (sleep difficult). At the time of the report, PAIN IN EXTREMITY (pain in her  left arm), LIMB DISCOMFORT (hardly can move her left arm), PARAESTHESIA (tingling), HYPOAESTHESIA (numbness), MOBILITY DECREASED (mobility decreased), MUSCULAR WEAKNESS (weekness in arms) and INSOMNIA (sleep difficult) outcome was unknown and VACCINATION SITE PAIN (pain in left arm at site of where shot was given) had not resolved.            Patient historical condition includes remove thyroid with an unknown date.  No treatment medication was provided.   This case was linked to MOD-2021-315380 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Sep-2021: Significant Follow up
Patient arm around injection site red, swollen, and warm to touch. The arm had also blistered at the injection site. Patient went to physician who stated that vaccine was given to low on the arm and should have been given higher. The physician put the patient on VALTREX prophylactically.
Narrative:  Pt had fever of 102 degrees F 2-3 hours after influenza vaccine, and shortness of breath. Pt was taken to the hospital pneumonia was ruled out. His diagnosis was felt to be "COPD exacerbation" -- Team decided in the futre ot should have regular influenza vaccine not high dose influenza vaccine
Swelling/ tenderness/ pain/ redness at the site (IM) of the vaccines on (Rt) & (Lt) thigh.
covid; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (covid) in an elderly female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Concurrent medical conditions included Type 1 diabetes mellitus (over 65 years of age) and Kidney disorder. Concomitant products included NIRMATRELVIR, RITONAVIR (PAXLOVID) for Kidney disorder, INSULIN for Type 1 diabetes mellitus.    On an unknown date, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 07-Dec-2022, the patient experienced COVID-19 (covid). At the time of the report, COVID-19 (covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Dec-2022, SARS-CoV-2 test: Positive. On an unknown date, Glomerular filtration rate: between 50 and 60.         Patient age was over 65 years. Patient received two regular Moderna Covid-19 vaccines. Treatment medication was not reported.   This case was linked to MOD-2021-048086 (Patient Link).
A inner lump has form in his left shoulder blade straight back from the injection site. He is saying it is painful and it hurts all the time. He also had a runny nose but that since has stopped.
Initial unsolicited report received from pharmacist on 14 October 2016. This case involves 82- year-old female patient who was vaccinated with dose of Fluzone HD (Batch number: UI725AA, expiration date 28 May 2017, dose was not reported) intramuscularly in right deltoid on an 12 October 2016. Patient Illness at time of vaccination reported as patient was on continuous oxygen therapy and pre-existing physician diagnosed allergies, birth defects and medical conditions include Chronic Obstructive Pulmonary Disease (COPD), Diabetic, CVD (Cardiovascular disease). Concomitant medication was not reported. On 14 October 2016, two days following vaccination patient had a large area of redness at the injection site and her arm felt funny like it had malaise. Lab data and corrective treatment was not reported. Outcome of events was reported as unknown. List of documents held by sender: none.
MOM REPORTS FEVER STARTED ON TUESDAY AT 2:30 AM , AFTER GETTING VACCINES ON MONDAY AFTERNOON. MOM REPORTS GIVING TYLENOL AND MOTRIN TO KEEP FEVER DOWN, BUT FEVER RETURNS.
HCP calling to report that PROQUAD was administered after undergoing a TE. No adverse affects reported. Caller stated this occurred in February 2023.          ?    Names of vaccines involved (including lot/exp): PROQUAD (Lot: W019631, Expiration: 1; No adverse affects reported; This spontaneous report has been received from a nurse concerning to a patient of unknown age and gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.  On an unspecified date, the patient was vaccinated with an improperly stored dose of v Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) 0.5 mL (dose number, route of administration and anatomical location were not provided) (lot#: W019631, expiration date: 19-DEC-2024) as prophylaxis (product storage error). No adverse event was reported. The temperature excursion was 13.5 F, for a total timeframe of 3 hours and 5 minutes. No previous temperature excursion were reported. No further information was provided.
My left arm hurt and it was hard to lift above my head. It has remained painful and I am having difficulty using it.
Employee C/O tongue numbness, right arm very tingly and r thumb numbness 15 minutes after receiving shot. Took 50mg of Benadryl po at worksite. Sent to the ER for treatment.
Fever (lowest: 99.7, highest: 101.7), fatigue and headache for about 30 hours
I noticed swelling on my underarm on the right side beginning mid day yesterday (2021-04-07).  Swelling was not noticeable at first, it was first noticed because of tenderness which continues to today (2021-04-08).  Swelling became noticeable overnight or this morning.  Only slightly tender to direct touch (was initially not at all), most of tenderness is felt from moving arm back to position at side.  No other symptoms.  Sent message to PCP today (2021-04-08) about symptoms but have not heard back.  Currently just observing
This spontaneous report was received from a Physician via a healthcare worker to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (lot # L019835 and expiration date 23-MAR-2017) 0.5 ml, (dose number and route were not provided). Concomitant medications were not reported. On an unknown date, the patient experienced "severe reactions". Therefore, the patient visited an unspecified emergency room. The outcome of the adverse reaction was unknown. The primary reporter did not provide the causality between PNEUMOVAX 23 and the adverse reaction. This is one of two reports from the same reporter. Additional information has been requested.
Phone call from mom. Red raised very sore knots bigger than the size of a quarter. Slept with ice packs on. Doctor told her to take Benadryl.
Woke up with a temperature of 99.5; Has a little soreness where the injection was; Feels a little rundown; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Woke up with a temperature of 99.5), VACCINATION SITE PAIN (Has a little soreness where the injection was) and FATIGUE (Feels a little rundown) 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 24-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced VACCINATION SITE PAIN (Has a little soreness where the injection was) and FATIGUE (Feels a little rundown). On 24-Aug-2021, the patient experienced PYREXIA (Woke up with a temperature of 99.5). At the time of the report, PYREXIA (Woke up with a temperature of 99.5), VACCINATION SITE PAIN (Has a little soreness where the injection was) and FATIGUE (Feels a little rundown) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.5 (High) woke up with a temperature of 99.5.         No concomitant medications were reported. No treatment medications were reported.
2 hours after 2nd Covid vaccine she was sitting quietly @ home playing with baby on floor & suddenly felt increased heart rate & dizziness. Later that day, she developed fever/chills/soreness, & weakness with exertion. That evening she took 200mg Ibuprofen & twice the next day. The day after vaccination had increased body aches, fever, & chills, along with weakness. 2 days after vaccination, had tightness in chest & tenderness on chest well with palpitation. Also had an episode of tachycardia. PERICARDITIS.
I started having extremely high blood pressure after never having had it before. I ended up in the hospital. I was pregnant and due July 7th and had the baby on April 7th at 27 weeks, she weighed 1 pound and 12 ounces. She is alive and in NICU at this time. I am not sure the two are related, but it happened very suddenly after the vaccine so I just wanted to be sure someone knew in case it was something that someone needed to be aware of. I went to the hospital a total of 24 days over three trips, the final hospital admittance was 14 days from April 1-14th with delivery being on the 7th. At this time the permanent damage and birth defects are unknown and we are working through everything, I am not sure what all is my own health or the vaccine, I just want to report it to help any kind of potential progress with the vaccine and ending the pandemic.
Breakthrough case admission after 3 vaccines  Moderna 3/1/21 Lot# 043L20A;  Moderna 4/1/21 Lot# 038K20A;  Moderna 11/11/21 Lot# 024C21A
Eyes were full of pus and red and swollen. The next morning they were crusty and swollen.  Today, 3 days later, the upper eyelids are still swollen near the nose.
My appointment on March 18, 2013, with Dr. and the preceding lab work was a routine, semi-annual check up, mainly to determine my current cholesterol numbers. The doctor noticed in his records that I was overdue for my second and final pneumonia vaccination. I had my first vaccination on Nov. 2, 2006, when I was 63 years old. The medical assistant gave me the shot and it was painless, as I commented to her. But about 7 hours later, around suppertime, I felt uncomfortable pain in the left shoulder at the site of the vaccination. I couldn't sleep on that side that night because the pain would awaken me. The next morning I counted 9 unconnected, slightly raised red blotches in my upper arm. Itching was very minor, but the pain and redness continued for 4-5 days. I called the doctor on the 4th day (March 21), but because I had no other adverse effects and the redness was gradually fading, it was determined I needn't come in for an appointment. The nurse did say if I had any breathing problems to go to the ER immediately. By Sunday, March 24, the redness had disappeared. The nurse on the phone suggested taking BENADRYL if I had some, but I didn't. As of this date, I feel fine.
woke at 3AM very dizzy, light headed and nauseous, leg very painful and hard to walk
I had an ischemic  stroke. I had the vaccine on April 8, 2022 and the stroke on April 21, 2022.  For a few minutes I could not form words and then it passed.
On 3/13/21 I started to notice a buzz sound in ny head when trying to take a nap. A High pitch  sound like static. It hasn?t  gone away since then. Im seeing an ENT on 3/16/21 to have this checked.  About 25 minutes after my covid shot I felt  a strong cold feeling on the top of my head  for about 30 -60 minutes . It went away. Now I wonder if this was also related.
Tdap and MMR given at the same time (Manufacturer unknown) This was the 2nd Tdap and 2nd MMR.   He began running a low grade fever just hours later - 99.7. The next day, July 24th, he had a higher fever up to 102.4, headache lethargy, swollen glands, nausea, light sensitivity. sore throat. I took him in to urgent care to be evaluated and because of his red throat a culture was done to rule out strep throat. It was negative. He continued to have a fever for 4 days. On Monday, August 30th he developed a rash on his upper chest and back. The rash was small red dots that lasted for a few days and were no accompanied with a fever. He continues to have a problem with burping/belching that seemingly started right after these shots as well.
Muscle at injection site sore, slightly red, and warm from day one. Three days later it started to itch. The itch is felt strongest below the injection site and stretches almost to elbow. No apparent rash but the itch can be rather intense.
Hives on thigh; This is a spontaneous report from a contactable consumer. A 48-year-old female patient (non-pregnant) received bnt162b2 (BNT162B2 solution for injection, Lot Number was EN6205, Expiration date: Not reported), dose 1 via an unspecified route of administration, administered in Arm Right on 11Mar2021 16:00 as 1ST DOSE, SINGLE for covid-19 immunisation. Patient was not pregnant at the time of vaccination. The patient was had not known allergies. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID. The patient medical history and concomitant was not reported. It was reported that the patient experienced hives on thigh on 12Mar2021 15:00. No Treatment was received for the event. The outcome of the event was recovering.   No follow-up attempts are possible. No further information is expected.
Information has been received from a physician concerning a 9 year old (previously reported as 4 years old) male student with no medical history and no allergies who on 04Feb1998 was vaccinated with a dose of varicella virus vaccine live. There was no illness at the time of vaccination. It was unknown if the patient was on concomitant therapy. On 05Apr2003 the patient developed full blown chicken pox with about 100 lesions. It was described as moderate to severe, not mild. Unspecified medical attention was sought. No diagnostic lab tests were performed. Subsequently, the patient recovered completely from his varicella illness, "but it took over a week". No further information is expected.
4/6/09 Called to report pain in (L) deltoid area - started same night after ADACEL "felt like in the shoulder joint". No relief with TYLENOL. Worse next morning - some relief with VICODIN. Denies redness or swelling. No fever. Pain gradually resolved over 3 weeks. No further problems.
This spontaneous report as received from a physician via company representative refers to an unspecified number of patients of unknown age and gender. No information on patients' medical history, concurrent conditions or concomitant medications was provided. On an unknown dates, unspecified amount of patient presented with shingles after receiving the doses of ZOSTAVAX injection (dates, dose, lot# and expiration date were not reported). The outcome of shingles and the causality between shingles and ZOSTAVAX were not provided. Additional information is not expected as the reporter did not wish further contact.