chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Since receiving the vaccine, my menstrual periods?normally very light?have become heavy in flow and accompanied by migraine headaches, intense abdominal cramping, and body aches. My menstrual periods are usually a non-event, but since getting the COVID vaccine, I am finding it difficult to carry on as usual during my period. To date, this has occurred over three menstrual periods.
Patient states she got her second Moderna shot at 12-1pm at out facility,pharmacy. That next morning, at 3am, she began experiencing general chest pain that gets worse as she tries to take a deep breath and triggers a cough, as well as low back pain "near her kidneys."
No adverse effects reported; Multiple patients were vaccinated with improperly stored ROTATEQ on multiple dates; Information has been received from a medical assistant concerning a patient of unknown age, gender and race. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 14-FEB-2019, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally for prophylaxis (lot number R021055 with expiration date in 01-APR-2020) (strength and anatomical location were not provided).  The Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was stored at an unknown temperature for an unknown time frame. There was a previous temperature excursion and the call was because of a data logger.  No adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA001848: US-009507513-1907USA001849: US-009507513-1906USA011434: US-009507513-1907USA001793: US-009507513-1907USA001794: US-009507513-1907USA001795: US-009507513-1907USA001796: US-009507513-1907USA001797: US-009507513-1907USA001798: US-009507513-1907USA001799: US-009507513-1907USA001800: US-009507513-1907USA001801: US-009507513-1907USA001802: US-009507513-1907USA001803: US-009507513-1907USA001804: US-009507513-1907USA001805: US-009507513-1907USA001806: US-009507513-1907USA001807: US-009507513-1907USA001808: US-009507513-1907USA001809: US-009507513-1907USA001810: US-009507513-1907USA001811: US-009507513-1907USA001812: US-009507513-1907USA001813: US-009507513-1907USA001814: US-009507513-1907USA001815: US-009507513-1907USA001816: US-009507513-1907USA001817: US-009507513-1907USA001818: US-009507513-1907USA001819: US-009507513-1907USA001820: US-009507513-1907USA001821: US-009507513-1907USA001822: US-009507513-1907USA001824: US-009507513-1907USA001825: US-009507513-1907USA001826: US-009507513-1907USA001827: US-009507513-1907USA001828: US-009507513-1907USA001829: US-009507513-1907USA001830: US-009507513-1907USA001831: US-009507513-1907USA001832: US-009507513-1907USA001833: US-009507513-1907USA001834: US-009507513-1907USA001835: US-009507513-1907USA001836: US-009507513-1907USA001837: US-009507513-1907USA001838: US-009507513-1907USA001839: US-009507513-1907USA001840: US-009507513-1907USA001841: US-009507513-1907USA001842: US-009507513-1907USA001843: US-009507513-1907USA001844: US-009507513-1907USA001845: US-009507513-1907USA001846: US-009507513-1907USA001847: US-009507513-1907USA000952: US-009507513-1907USA000989: US-009507513-1907USA000962: US-009507513-1907USA000988: US-009507513-1907USA000963: US-009507513-1907USA000953: US-009507513-1907USA000959: US-009507513-1907USA000968: US-009507513-1907USA000967: US-009507513-1907USA000964: US-009507513-1907USA000966: US-009507513-1907USA000954: US-009507513-1907USA000969: US-009507513-1907USA000970: US-009507513-1907USA000965:
Pain and Swelling at the injection site; Swelling at the injection site; Could not move her arm; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2020, the patient received the 1st dose of Shingrix (intramuscular). In September 2020, less than a week after receiving Shingrix, the patient experienced pain in arm, injection site swelling and injected limb mobility decreased. The patient was treated with paracetamol (Tylenol) and baclofen. On an unknown date, the outcome of the pain in arm, injection site swelling and injected limb mobility decreased were recovering/resolving.   It was unknown if the reporter considered the pain in arm, injection site swelling and injected limb mobility decreased to be related to Shingrix.  Additional details were provided as follows: On 23rd or 24th September 2020, the patient received first dose of Shingrix vaccine in right arm. The patient had pain and swelling at the injection site after receiving the vaccine. The pain spread throughout the entire right arm and became so severe that she could not move her arm. The patient went to her physician who recommended Tylenol. The patient also went to the emergency room where the physician recommended Tylenol and prescribed baclofen. The pharmacist stated that the patient was improving. The reporter did not consent to follow up.
Severe aches and pains. Chills. No nausea. Mostly just really severe aches and pains that last about a week. I couldn't lay down, I could not even sit in a chair. Every nerve ending where anything would touch me it would hurt me. I took some oxycodone for the pain which seemed to help relieve it a bit and I only took it once.
Pt presented to the ED on 7/16/22 w/abdominal pain. Had extensive work up and was COVID positive. Was discharged to home on Paxlovid. The following day 7/17/22 she received a call from the ED to return for 2/2 positive blood cultures for coag neg staph. She was admitted and during that time had a low grade fever and briefly required oxygen-2L per NC. She remained on Paxlovid and was given IV dexamethasone. Repeat blood cx were negative. No other tests remarkable and she was discharged to home on 7/20/22
No symptoms or further details reported. No other AE; 11 year old patient received their second GARDASIL 9 dose too early.  First dose was was on 09/12/2023 and second dose was administered on 10/06/2023; This spontaneous report was received from a medical assistant and refers to an 11-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 12-SEP-2023, the patient was vaccinated with first dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) as prophylaxis (lot#, expiration date, route of administration, anatomical location, was not reported), then on 06-OCT-2023, the patient received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #1957404, expiration date: 05-OCT-2025, administered for prophylaxis (strength, anatomical location,  and route of administration were not provided) (Inappropriate schedule of vaccine administered). No symptoms or further details reported.
Heart Failure; troubled breathing; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of CARDIAC FAILURE (Heart Failure) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COPD since an unknown date and Arteriosclerosis since an unknown date.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-May-2021, the patient experienced DYSPNOEA (troubled breathing). On an unknown date, the patient experienced CARDIAC FAILURE (Heart Failure) (seriousness criteria death and medically significant). The patient died on 29-May-2021. The reported cause of death was Chronic obstructive pulmonary disease, Heart failure and Atherosclerosis. It is unknown if an autopsy was performed. At the time of death, DYSPNOEA (troubled breathing) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       No concomitant product information was provided.  No treatment information was provided.  This is a 66-year-old male patient who experienced CARDIAC FAILURE and died 30 days after receiving mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. unknown). Patient had a concurrent CHRONIC OBSTRUCTIVE PULMONARY DISEASE, and ARTERIOSCLEROSIS.  It is unlikely, that the events are related to the vaccine based on long standing illness of COPD and Arteriosclerosis. Very limited information has been reported at this time. Further information is expected.; Sender's Comments: This is a 66-year-old male patient who experienced CARDIAC FAILURE and died 30 days after receiving mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. unknown). Patient had a concurrent CHRONIC OBSTRUCTIVE PULMONARY DISEASE, and ARTERIOSCLEROSIS.  It is unlikely, that the events are related to the vaccine based on long standing illness of COPD and Arteriosclerosis. Very limited information has been reported at this time. Further information is expected.; Reported Cause(s) of Death: Chronic Obstructive Pulmonary Disease; Heart Failure; Atherosclerosis
Pt came in 3/3/14 due to body itch Dr. prescribed BENADRYL. 3/14/14 pt came in due to rash to hands. Dr. Dx: allergic to HPV prescribed BENADRYL.
I (medical assistant) was on the phone and the physician asked me to administer vaccination to patient. I thought she said TDaP. I administered the TDaP. The immunization that was supposed to be given was Hep B. This TDaP was not ordered.
pt lost hearing in rt ear. Per follow-up dated 09/28/00, the pt has total loss of hearing in right ear.
Chills; Low grade fever; Complete body muscle aches; Mild nausea; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 01May2021 at 15:15 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included sulfonamide allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included fluticasone propionate (FLONASE), fexofenadine hydrochloride (ALLEGRA), xylitol; sodium chloride (XLEAR NASAL SPRAY) and ethinylestradiol; norgestimate (MILI) all from an unknown date for an unspecified indication. The patient previously took amoxicillin; clavulanic acid (AUGMENTIN) from an unknown date for an unspecified indication and experienced drug allergy. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 09Apr2021 at 13:15 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. On 02May2021 at 03:30, the patient experienced chills, low grade fever, complete body muscle aches, mild nausea, fatigue that lasted almost 24 hours. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. Clinical outcome of the events chills, low grade fever, complete body muscle aches, mild nausea was recovered on an unspecified date in May2021. Whereas, the clinical outcome of the event fatigue recovered on 03May2021.  No follow-up attempts are needed. No further information is expected.
BUD date was 15-Jan-2022, On 26-Jan staff brought it to attention that it was still in fridge and expired; BUD date was 15-Jan-2022 but 5 doses had been given and it was noticed on 26-Jan-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (BUD date was 15-Jan-2022 but 5 doses had been given and it was noticed on 26-Jan-2022) and PRODUCT STORAGE ERROR (BUD date was 15-Jan-2022, On 26-Jan staff brought it to attention that it was still in fridge and expired) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2022 at 5:42 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 22-Jan-2022 at 5:42 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (BUD date was 15-Jan-2022 but 5 doses had been given and it was noticed on 26-Jan-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (BUD date was 15-Jan-2022, On 26-Jan staff brought it to attention that it was still in fridge and expired). At the time of the report, EXPIRED PRODUCT ADMINISTERED (BUD date was 15-Jan-2022 but 5 doses had been given and it was noticed on 26-Jan-2022) and PRODUCT STORAGE ERROR (BUD date was 15-Jan-2022, On 26-Jan staff brought it to attention that it was still in fridge and expired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  No treatment medication information was provided.  On 16-Dec-2021, the vaccine was pulled from freezer. Beyond use date was reported as 15-Jan-2022, which was printed in red and taped to the top of boxes. On 26-Jan-2022, staff brought it to attention that it was still in the freezer and expired and total 5 doses had been given at that point. Patient was notified of the error and patient denied any adverse effects.
pt recv vax 24APR97 430PM & 25APR97 red 1.5cm sore;26APR to 30APR97 grew in size to 8-10cm induration erythema & vesicular peripheral eruption;local fever;no gen sx;no f/c, n/v, SOB, syncope;
This case was reported by a consumer and described the occurrence of passed out in a 17-year-old female patient who received BEXSERO. On 30th March 2016, the patient received BEXSERO. On 8th April 2016, 9 days after receiving BEXSERO, the patient experienced passed out (serious criteria GSK medically significant), nausea, dizziness and fainting. On 9th April 2016, the patient experienced appetite absent, stomach pain and tiredness. On an unknown date, the outcome of the passed out, nausea, dizziness, fainting, appetite absent, stomach pain and tiredness were unknown. It was unknown if the reporter considered the passed out, nausea, dizziness, fainting, appetite absent, stomach pain and tiredness to be related to BEXSERO. Additional details were received as follows: This case was reported by the patient's mother. On 08 April 2016, 9 days after the vaccination, the patient experienced nausea, dizziness and passed out or fainted for two minutes. The mother took the patient to the emergency room. In emergency room, they did Electrocardiogram and urine test. No findings were observed. On 09 April 2016, the patient was still experiencing nausea, did not want to eat, stomach ache and very tired. In the emergency room, the mother did not remember to tell the physicians that, the patient had received a dose of BEXSERO. When she remembered the vaccine administration, she called the nurse's line and they advised the events were from BEXSERO. The mother of the patient wanted to know how long the side effects would continue.
Severe nausea; Vomiting; Low fever; Chills; This is a spontaneous report received from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine; Lot number: ep 6955), via an unspecified route of administration on left arm on 19Mar2021 at 12:45 (at the age of 27 years), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have any allergic conditions. Concomitant medications included SEASONIQUE, gabapentin (MANUFACTURER UNKNOWN) and melatonin (MANUFACTURER UNKNOWN) started on an unknown date used for an unknown indication. Prior to vaccination, the patient had no symptoms associated for COVID-19. Since the vaccination, the patient was not tested positive for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the suspect vaccine. On 19Mar2021 at 21:00, the patient experienced severe nausea and started vomiting. The patient had a low fever and chills and couldn't stop vomiting. The patient couldn't keep water down for about 4 hours. The clinical outcome of events severe nausea, vomiting, low fever and chills were resolved on an unknown date in Mar2021.    No follow-up attempts are needed. No further information is expected.
Within 24-48 hours (besides the instantaneous soreness) it became itchy and really warm/sore to the touch at the injection site. I believe this is called "Covid Arm" and I just wanted to report my case.
Pt received flu shot at approximately 10:00 hrs this day by city nurses at station 2. Around 13:00 hrs pt started to sneeze and cough, as well as sinus draining and swelling into left eye. Pt states he has some more shortness of breath and describes it as labored. Pt also has some redness on right forearm. Pt treated and transported to ER. Pt has some wheezing bilateral and treated with BENADRYL and O2
Caused slight redness on her arms; This spontaneous case was reported by a patient and describes the occurrence of ERYTHEMA (Caused slight redness on her arms) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product PALBOCICLIB (IBRANCE) for an unknown indication.    The patient's past medical history included Injection (Patient gets an injection for her bones every 3 months). Concurrent medical conditions included Immunocompromised.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. and PALBOCICLIB (IBRANCE) (unknown route) at an unspecified dose. On an unknown date, the patient experienced ERYTHEMA (Caused slight redness on her arms). At the time of the report, ERYTHEMA (Caused slight redness on her arms) outcome was unknown.            No concomitant medications were reported.  The first two doses of Moderna vaccine only caused slight redness on her arm but no other reaction. Patient was currently on Ibrance but listed no side effects.  Treatment information was not provided.  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.   This case was linked to MOD-2021-624969 (Patient Link).
Client's mother called the Health Department at 3:48pm and left a message stating that her daughter "passed out and had a seizure" in the car on the way home after being vaccinated. Client was being taken to Medical Center.
received her second dose of Shingrix about one year prior to developing shingles/suspected vaccination failure; shingles; rash from mid back to mid abdomen; side pain; This serious case was reported by a nurse via sales rep and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular, unknown deltoid) and the 1st dose of Shingrix. On an unknown date, 1 year after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: received her second dose of Shingrix about one year prior to developing shingles/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles), rash (Verbatim: rash from mid back to mid abdomen) and pain (Verbatim: side pain).The outcome of the vaccination failure, shingles, rash and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, rash and pain to be related to Shingrix and Shingrix.   It was unknown if the company considered the vaccination failure, shingles, rash and pain to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 13-SEP-2023 The GlaxoSmithKline Field Representative reported that a nurse practitioner stated that a patient (DOB, age and initials were unknown) presented to the office with side pain and rash from mid back to mid abdomen and was diagnosed with shingles. The patient had received her second dose of Shingrix about one year prior to developing shingles. Nothing else was reported. The reporter consented to follow up.  This case was considered as suspected vaccination failure as details regarding laboratory test confirming shingles were unknown at the time of reporting.
This spontaneous case was reported by a nurse and describes the occurrence of VISION BLURRED (Blurred vision) and HEADACHE (Headache) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 027H21B) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for an unknown indication.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2020, the patient experienced VISION BLURRED (Blurred vision) and HEADACHE (Headache). At the time of the report, VISION BLURRED (Blurred vision) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment reported
Pt c/o pain (L) shoulder at site of vaccine pain with motion, decreased ROM, pain down (L) arm at times.
After the shot I worked on Computer type things till 3am. Had a sore arm and had slight chills off and on..  Didnt take anything for it. I was not drinking any fluids and didnt eat dinner that night. The morning of 10/26 tried to pop out of bed as normal but ended up directly back in bed. Dizzy and/or blacked out. It wasn't a normal dizzy that I've felt before. Took a moment to think about what just happened and sat up slowly. I had a sinking feeling and had to prop my self with a hand on the wall. I was dizzy/dazed but not exactly a spinning type of dizzy. I felt achy and feverish throughout the day... Stayed home from work. Took some Aleve in the evening as I was getting feverish and felt hot to the touch. (Couldnt find our thermometer but my spouse's hand felt very cold to me and I felt hot to her.)
A LITTLE OVER ONE MONTH AFTER MY 2ND MODERNA DOSE, I DEVELOPED JOINT STIFFNESS AND PAIN. SEVERE PAIN AND STIFFNESS  IN MY JAW, LEFT SHOULDER. RIGHT ANKLE. EXTREME PAIN IN MY RIGHT SHIN NECESSITATING ICING NIGHTLY, ELEVATION, AND OTC PAIN RELIEF. THE BODY AREAS NOTED THAT SEEMED TO BE AFFECTED THE MOST , WERE BODY AREAS THAT WERE SUBJECT TO PREVIOUS TRAUMA. THE ACHES AND BODY PAIN REMAIN, BUT ARE TOLERABLE.  AFTER THE SECOND MODERNA DOSE IS FELT AS IF MY BODY WAS ATTACKING ITSELF. MY DOCTOR HAD ME TESTED FOR RHUMATOID ARTHRITIS AND  MS
patient started getting chills , shaking , nausea, vomiting and diarrhea starting 3 to 4 hours after vaccine. Went to bed and woke up fine , just a headache in the morning
Pt rec'd '5 year' shots in office on 6/02/17. Seen 6/03/17 in office for 4 1/2 x 3 cm area of redness (RT) arm. Reports increased redness and pain at site and temp at 100 F. Tx= Ice packs to site. If itching occurs - HC cream or BENADRYL. (ER if pain).