chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She didn't get the 2nd dose on time/second dose delayed beyond 36 days; She was ill; This spontaneous case was reported by a nurse and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (She didn't get the 2nd dose on time/second dose delayed beyond 36 days) and ILLNESS (She was ill) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (She didn't get the 2nd dose on time/second dose delayed beyond 36 days) and ILLNESS (She was ill). At the time of the report, INTENTIONAL PRODUCT USE ISSUE (She didn't get the 2nd dose on time/second dose delayed beyond 36 days) and ILLNESS (She was ill) outcome was unknown. Not Provided      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 relevant concomitant medications reported.  No treatment information was provided.
No additional AE reported; A vaccine coordinator reported PROQUAD was administered after a temperature excursion.; This spontaneous report was received from a vaccine coordinator referring to a patient of unknown age and gender. Concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 06-APR-2022, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) (strength, dose and route were not reported; lot # U022729, expiration date: 16-JAN-2023) for prophylaxis (product storage error).       It was reported that the suspect vaccine was exposed to a temperature of minus 11.83 degree Celsius for a time frame of 15 minutes. The previous temperature excursion included 9.37 degree Celsius for a time frame of 2 hours and 30 min.    No additional adverse event (AE) information was provided (no adverse event).  This is one of the multiple cases reported by the same reporter.; Sender's Comments:  US-009507513-2204USA002815:
This case was reported by a pharmacist via call center representative and described the occurrence of autoimmune hemolytic anemia in a 53-year-old female patient who received BOOSTRIX (batch number 4HY3T, expiry date unknown) for prophylaxis. Co-suspect products included FLAURIX QUADRIVALENT 2018-2019 season) (batch number 55E34, expiry date unknown) for prophylaxis. On 23rd August 2018, the patient received BOOSTRIX .5 ml and FLUARIX QUADRIVALENT 2018-2019 season .5 ml. On 26th August 2018, 3 days after receiving BOOSTRIX and FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced autoimmune hemolytic anemia (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the autoimmune hemolytic anemia was unknown.  The reporter considered the autoimmune hemolytic anemia to be possibly related to BOOSTRIX and FLUARIX QUADRIVALENT 2018-2019 season. Additional details were provided as follows: The reporting healthcare professional (HCP) was in patient pharmacist at the local medical center. The HCP stated that the patient presented to the emergency room (ER) at the medical center on 26th August 2018 and had been diagnosed with autoimmune hemolytic anemia. The HCP stated that the patient was still hospitalized and that the relationship between the vaccines and the patient's diagnosis was unclear but they at the time of reporting were listing the patient as 'allergic to BOOSTRIX as an abundance of caution'. The HCP did not have the vaccine details or expiration date for this adverse event. The HCP stated that the only thing that the medical staff had found might have possibly caused this medical condition for this patient was the recent vaccinations.
administration of improperly stored vaccines; This spontaneous report as received from an office manager to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 22-FEB-2021, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2ml, lot # 1691300, expiration date: 24-NOV-2021, orally for prophylaxis.    Administered dose of vaccine underwent the temperature excursion of 54 degrees Fahrenheit for 43 hours. Digital data logger was involved. There were no previous excursions reported.
Two days after receiving flu shot patient reported feeling extremely weak with a loss of appetite. Then had severe diarrhea.
Information was received from an approximately 69 year old female patient with vancomycin and penicillin allergies and heart disease. In  approximately 2008 (reported as "about 6 years ago"), the patient was vaccinated with ZOSTAVAX (dosage and route of administration not provided) for the prevention of shingles. Concomitant therapies included vitamins (unspecified), B12, B6 and folic acid. A few months ago, the patient developed shingles after being vaccinated with ZOSTAVAX. The patient reported that her experience was horrible. She had pains (unspecified locations), it "infected her breathing and lungs." The patient could not sleep because of the pain. She also mentioned having feelings of fever blisters around her lips and feeling very fatigued. She saw her doctor and was treated with acyclovir (manufacturer unknown). The outcome of the events was nit reported. Additional information has been requested.
Developed fibromyalgia 04/20/2001. Diagnosed with asthma 04/30/2003.
Arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03DA21A) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm was sore). At the time of the report, PAIN IN EXTREMITY (Arm was sore) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  No treatment medications were reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Follow-up received updated event outcome and vaccine start date.
Flu-like symptoms (joint and muscle pain, headache, malaise) and injection arm pain, starting ~30 hours after vaccination, resolved by 4/10/21 Bumpy, non-itchy rash on injection forearm resolved by 4/13/21 Tongue inflammation and pain, resolving 4/13/21
Itchy rash all over my body several days ago, treated with cortisone cream and antihistamine tablets
the Dose which was given to him was not stored at correct temperature; Soreness of the arm; Chills; Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT STORAGE ERROR (the Dose which was given to him was not stored at correct temperature), PAIN IN EXTREMITY (Soreness of the arm), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Apr-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. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (the Dose which was given to him was not stored at correct temperature), PAIN IN EXTREMITY (Soreness of the arm), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PRODUCT STORAGE ERROR (the Dose which was given to him was not stored at correct temperature), PAIN IN EXTREMITY (Soreness of the arm), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter.
pt recv vax 24MAY96 & 12APR(7 pt devel about 20 lesions that were on face, chest, back, & arms;pt father reported that 1wk post vax family travelled to Turkey & child exposed to chickenpox;pt devel varicella w/less than 20 lesions;
In December 24th late in the evening I experienced sweats followed by extreme chills for a few hours. I also had upset stomach and diarrhea throughout the day. All symptoms only lasted the day after injection.
It was reported that a 32 year old male received second dose of JE-VAX vaccine,lot number EJN200A on May 02, 2002. Twelve hours later, pt experienced itchy lateral surface down both hands. Pt self medicated with Benadryl and it went away.
After receiving MMR-V, KINRIX was at lab and noted (L) periorbital swelling --> (L) facial swelling --> flushed skin abdomen/arms --> hives face and more swelling face and swelling ears. No wheezing or trouble breathing --> received offer BENADRYL orally and EPI IM.
Patient received a Moderna COVID19 booster dose that was drawn from a Moderna vial that was stored at room temperature for >20 hours after 1st puncture.
horrible reaction; This case was reported by a consumer and described the occurrence of erythema of extremities in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 1 week after receiving Shingrix, the patient experienced erythema of extremities. On an unknown date, the outcome of the erythema of extremities was unknown.   It was unknown if the reporter considered the erythema of extremities to be related to Shingrix.     Additional Information: GSK Receipt Date: 04-MAY-2022 Reporter's Comments: The case was self reported by the patient. The patient reported that patient received a dose of Shingrix vaccine one week after patient experienced horrible reaction. The patient was going to see a doctor and asked for any suggestions. Additional Supportive Information: The follow-up would not possible as no contact details were available.
2 days after administration of vaccines, patient presented to Emergency department with erythema and swelling of left anterior thigh.  Thigh was non-tender and patient did not have fever.
Diarrhea; Emotional; Migraine; Arm swelling; Arm soreness; This is a spontaneous report from a non-contactable consumer, the patient. A 18-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration on 07May2021 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. The patient's medical history was reported as not applicable. The patient had no known allergies. 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 were not reported. On 08May2021, the patient experienced diarrhea, migraine, arm swelling and arm soreness and was emotional. 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. The clinical outcome of the events diarrhea, emotional, migraine, arm swelling and arm soreness were resolved on an unknown date in May2021.  No follow-up attempts are possible. No further information is expected.
Within 6 hrs - violent shakes, night sweats (linen soaked), sore throat, cough did not go to ER. probably should have - called provider - said side effects to be expected.
tongue went numb; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number Unknown, MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: HYPOAESTHESIA ORAL (non-serious), outcome "unknown", described as "tongue went numb".  Additional information: (Case narrative): The patient was also not the reporter. Reporter seriousness for tongue went numb was provided as unspecified. Is Covid vaccine a Pfizer product: Unspecified. Covid vaccine manufacturer was unspecified. Dates and NDC number for Covid vaccine was unspecified. Reason for no lot number: of Covid vaccine: Complainant does not have the product with them at the time of call. Expiry Date of Covid vaccine was unknown. Other Products were unknown. Additional Context: Agent stated there was a consumer a patient on the line, did not wish to provide demographics, patient got booster shot on 21Jan2022, stated a few minutes after booster shot her lips started to get numb and her throat feels like it is closing and it is hard to swallow. Agent stated the caller was given Benadryl 30 minutes prior to the vaccine but it did not give any effect. Caller confirmed details provided by the transferring agent. Caller mentioned that a nurse told her that her tongue got numb after the booster shot, stated the nurses name was withheld, she was a female, an RN at the Clinic in the procedure center, stated she has no personal details to provide and did not know the nurse personally, product information unknown, no further details known or provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
New onset peripheral edema, found to have pericarditis and bilateral pleural effusions without apparent underlying cardiac pathology, infection, or malignancy. Inflammatory markers also elevated.
numbness and tingling to left side of face.  No facial droop.  No tongue swelling or throat closing
After receiving my second Modena vaccination, I began menstruating  again. I have been in meanopause for years. I have continued to have heavy bleeding every three weeks. I have had vaginal ultrasounds, biopsies and a DnC as well as the dosage of my progesterine decreased and am still bleeding.
COVID-19. I received my 2nd booster shot on 06/24/2022 and my COVID-19 symptoms started on 06/23/2022 at around 04:00AM low grade fever; nose clogged up; nasal congestions; cough. I tested positive on the 06/24/2022. The same day I did tele visit with a nurse prescribed me PAXLOVID for 5 days. I tested positive again for COVID-19 on 07/05/2022. I went to the urgent care to get treated for COVID-19. Urgent care prescribed me albuterol; prednisone; MUCINEX DM over the counter medication; doxycycline. I am currently on the medication.
The only side affect is a large (about 4 - 5 inches in diameter) red spot about 4-6 inches lower than the injection site. The spot is painful around that area, burning, itching and feels hot to the touch.
This spontaneous report as received from a certified medical assistant (reported also as: healthcare worker) refers to an unspecified number od patients of unknown age and gender. Information regarding patients drug reactions or allergies and medical history was not reported. On an unknown date, unspecified number of patients received improperly stored RECOMBIVAX HB (dose, route of administration, anatomical location, lot#, expiration date were not reported). Concomitant therapies were not 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 has been requested.
Symptoms began at approximately 7pm and lasted 4-5 hours. Complained of chills, achy, headache and upset stomache. Felt okay next morning.
COVID-19; COVID-19; Vaccination site pain/mild sore arm; mild sore arm; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4214557-00.  A 60 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 14Apr2021 (Batch/Lot number: unknown) at the age of 59 years as dose 2, single and intramuscular, administration date 17Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for psoriasis, psoriatic arthropathy. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19"; VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "Vaccination site pain/mild sore arm"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "mild sore arm". The action taken for adalimumab was unknown.  Causality for humira (adalimumab): The reporter's causality for the event(s) of vaccine caused a mild sore arm and covid was not provided and for Vaccination site pain and covid-19: not reported. Causality as per reporter for PFIZER BIONTECH COVID-19 Vaccine for events Vaccination site pain:  possible and for Covid-19 (covid-19) and mild sore arm: not reported   Clinical Course: On an unknown date, the patient experienced covid. In 2021, the patient experienced vaccine caused a mild sore arm and covid with humira (adalimumab). In 2021, the vaccine caused a mild sore arm resolved. It was unknown if patient was enrolled in a covid-19 vaccine trial. In 2021, the vaccine caused a mild sore arm resolved. Pfizer biontech covid-19 vaccine (tozinameran) was also considered suspect. It was unknown if patient was enrolled in a covid-19 vaccine trial.  The lot number for bnt162b2 was not provided and will be requested during follow up.number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the  information in the case report, a possible causal relationship between the events drug ineffective, suspected COVID-19 and vaccination site pain , Pain in extremity  and suspect drug BNT162B2 cannot be excluded.
Started having " covid arm "  rash on left arm two days after injection. After the 4th day whole left side of body broke out in itchy hives and rash. Lasted for a little over a week long.
States "I get anxiety attacks and that's what I thought was happening, (anxiety with difficulty breathing) but then my boyfreind noticed a welt on my arm 4 hours later and I knew it was an allergic reaction."  Accessed care 06/02/2010 and was given Benadryl.   Denies presence of rash.  Provider did not note swelling upon inspection of trachea per pt.  Swelling and redness noted at posterior right arm. No additional sob from that time until present.  Swelling now markedly decreased.
Itchiness; redness on arm below injection point; tenderness and around lymph node under arm.; pain under arm; Hard knot at injection site; Hard knot and tenderness at injectionpoint; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in right arm on 18Mar2021 at 12:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and high cholesterol. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN) and rosuvastatin (MANUFACTURER UNKNOWN) taken from unknown dates for unknown indications. Prior to vaccination, on an unknown date, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Since the vaccination, the patient was not diagnosed with COVID-19. On 18March2021, the patient experienced a hard knot and tenderness at injection site; on 19Mar2021, experienced pain under arm; on 20Mar2021, redness below injection point and tenderness around lymph node underarm and 3-4 days later to vaccination, experienced expanded redness on arm below injection point with pain and itchiness. Therapeutic measures were not taken as a result of the events. The clinical outcome for events vaccination site lump, vaccination site tenderness, armpit pain, itchiness, redness and lymph node tender were recovering.  No follow-up attempts are possible. No further information is expected.
got extremely weak, very weak in the shower and didn't know if she will be able to keep standing up; chest pain in my right side; my left leg started aching; my toes tingle like they have fallen asleep on that left side; heart was beating faster than what it should have been, they said she was tachycardic and her heart was racing; heart was beating faster than what it should have been, they said she was tachycardic and her heart was racing; Redness; back was all red, really red; The initial case was missing the following minimum criteria: unspecified product. Upon receipt of follow-up information on 01Apr2021, this case now contains all required information to be considered valid.   This is a spontaneous report from a contactable consumer reporting for herself. This 52 years old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EP7533) on 31Mar2021 at 09:30, for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient received the vaccine on 31Mar2021 at 9:30 and was fine all day until 7 o'clock at night. She went to take her shower and got extremely weak, very weak in the shower and didn't know if she will be able to keep standing up, so she got out of the shower, went upstairs; the weakness persisted and then she started feeling chest pain in her right side, her left leg started aching and her toes tingled like they had fallen asleep on that left side so she got scared and went to the emergency room where they kept her overnight. Her heart was beating faster than what it should have been, they said she was tachycardic and her heart was racing and that was why they kept her at the hospital. She also had redness, her back was all red, really red. They did lots of lab work and blood work, a stress test, an ultrasound on her left leg for blood clot and a CAT scan on her heart, all with unknown results. When probed about hospitalization, she stated to stay overnight. She was hospitalized on 31May2021 at about 19:30 and did not get out until 13:30 on 01Apr2021. Events outcome was unknown.