chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chills at night; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 03May2021 at 16:15 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. The patient had unspecified medical history. 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 vaccination. Concomitant medications included levothyroxine sodium (THYRONORM) and telmisartan (MANUFACTURER UNKNOWN); taken for unspecified indications from unknown dates and unknown if ongoing. On 04May2021 at 01:00, the patient experienced chills at night since the vaccination. The patient had no fever and no other reaction. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event chills at night was resolving at the time of the report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Patient started to notice Rt sided hearing loss  4hrs 15mins post COVID-19 Moderna 2nd dose. Conducted Audiology hearing test 3 weeks post second shot secondary to on-going and pronounced hearing loss within right ear.  Patient referred to ENT. ENT provider prescribed oral steroids for one week.  Hearing loss persisted with worsening of symptoms throughout treatment with steroids and at 1-wk post conclusion of steroid treatment. ENT performed a myringotomy of the right ear on 04 MAY 21, with no improvement of hearing post-procedure. Meanwhile additional symptoms have presented with difficulty swallowing water and oral secretions on right sided, with pinpointed right-sided headaches starting on 08 MAY 21.
SHOULDER FELT LIKE GOT A TETANUS SHOT; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced shoulder felt like got a tetanus shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of shoulder felt like got a tetanus shot was not reported. This report was non-serious.
Left arm began tingling immediately after shot 12/31/2020.  Within a short time entire arm was tingling all the way to fingertips of left hand. Felt similar to when a limb "falls asleep". Continued for 2 days. Thereafter tingling sensation reduced but has not disappeared. Slight tingling still present at fingertips of left hand as of 2/17/2021. Second dose received in right arm 1/21/21. Symptom did not occur in right arm.
This spontaneous report received from a registered nurse refers to a 13 months old male patient with no illness at time of vaccination. The patient's historical vaccines and concomitant therapies were not reported. The historical conditions included neonatal jaundice due to delayed conjugation from breast milk inhibitor, and left sided facial paisy noted at one month visit. The patient's concurrent conditions included hypermetropia  bilateral and Marcu Gunn jaw-winking syndrome evidenced with ptosis of eyelid left side noted at birth with some molding on that side. On 14-SEP-2018, the patient was vaccinated with an improperly stored first dose of M-M-R II, subcutaneously (SC) in the left thigh, lot # N026828 (expiration date: 27-SEP-2019, albumin status: rHA); with an improperly stored first dose of VARIVAX, SC, in the right thigh lot # R003300 (expiration date: 01-FEB-2020); with an improperly stored first dose of VAQTA intramuscularly (IM) in the left thigh, lot # R013858 (expiration date: 12-JUN-2019) and with an improperly stored fourth dose of PREVNAR IM, in the right thigh, lot # W11306 (expiration date not reported). The administered doses of the vaccines experienced a freezer temperature excursion (not specified) (product storage error) as recorded from a digital data logger which occurred at the time of storage in clinical practice. None patient experiences were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1809USA010598: US-009507513-1901USA002753: US-009507513-1901USA002754: US-009507513-1901USA002755: US-009507513-1901USA002756: US-009507513-1901USA002757: US-009507513-1901USA002758: US-009507513-1901USA002759: US-009507513-1901USA002760: US-009507513-1901USA002761: US-009507513-1901USA002762: US-009507513-1901USA002764: US-009507513-1901USA002765.
Chest pain, bilateral upper and lower extremity paresthesias, racing heart, hives/rash on neck, fever, fatigue.
Patient received expired dose of HEPLISAV-B; Initial Report Received on 13-May-2019, 14-May-2019, and 15-May-2019  An inventory specialist and a pharmacist both separately reported that a patient (age, gender and race not provided) was administered with HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization that was an expired dose.  Relevant medical history and concomitant medications were not provided.  On 13-May-2019, an inventory specialist reported that he received a phone call from a pharmacist, who was also the pharmacy store manager, who reported that an expired vial of HEPLISAV-B was sent to the pharmacist's store, and the vaccine was given to a patient on this date, two days after the expiration date (lot # 1033385, expiration date 11 May 2019). He reported that the patient's age, gender, and medical history/allergies were unknown, the provider's information was unknown, that it was unknown if adverse events were experienced, and that he would follow-up with the pharmacist for additional information.    On 14-May-2019, the inventory specialist reported that he would have the pharmacist contact Dynavax.  On 15-May-2019, the pharmacist from an outpatient pharmacy contacted Dynavax and confirmed that the patient received the expired HEPLISAV-B dose on 13-May-2019, confirmed that the dose was administered from a vial and provided the same lot # and expiration date as the inventory specialist, and reported that the patient did not experience any adverse events. The pharmacist refused to provide the patient's initials, date of birth, gender, or contact information. No other information was provided.  At the time of the report, the outcome of the event was unknown.  The reporter did not provide a seriousness assessment for the event.   Company comment: The company assessed the event of expired product administered as non-serious. The event of expired product administered is unlisted per HEPLISAV-B USPI.; Sender's Comments: The company assessed the event of expired product administered as non-serious. The event of expired product administered is unlisted per HEPLISAV-B USPI.
heart cath; Fluid on the lungs; short of breath; Did not get second shot due to illness; sore arm; not being able to stand up and being weak; Aching all over every joint; not being able to stand up and being weak; This spontaneous case was reported by a consumer and describes the occurrence of CATHETERISATION CARDIAC (heart cath) and PULMONARY OEDEMA (Fluid on the lungs) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included SACUBITRIL VALSARTAN SODIUM HYDRATE (ENTRESTO), LEVOTHYROXINE, METOPROLOL, FUROSEMIDE, POTASSIUM, WARFARIN, GABAPENTIN and METOLAZONE for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced CATHETERISATION CARDIAC (heart cath) (seriousness criterion hospitalization). On an unknown date, the patient experienced PULMONARY OEDEMA (Fluid on the lungs) (seriousness criterion medically significant), DYSPNOEA (short of breath), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not get second shot due to illness), PAIN IN EXTREMITY (sore arm), ASTHENIA (not being able to stand up and being weak), ARTHRALGIA (Aching all over every joint) and DYSSTASIA (not being able to stand up and being weak). On 17-Mar-2021, CATHETERISATION CARDIAC (heart cath) outcome was unknown. At the time of the report, PULMONARY OEDEMA (Fluid on the lungs), DYSPNOEA (short of breath), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not get second shot due to illness), PAIN IN EXTREMITY (sore arm), ASTHENIA (not being able to stand up and being weak), ARTHRALGIA (Aching all over every joint) and DYSSTASIA (not being able to stand up and being weak) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Negative) negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Cardiac catheterization on 17-Mar-2021.  Based on the current available information and temporal association between the use of the product and the start date of the events( cardiac catheterization, dyspnea, pulmonary oedema, dysstasia, asthenia, pain in extremity and arthralgia) a causal relationship cannot be excluded. However for the event of inappropriate schedule of Product administration for  mRNA-1273, causality is assessed as not applicable; 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( cardiac catheterization, dyspnea, pulmonary oedema, dysstasia, asthenia, pain in extremity and arthralgia) a causal relationship cannot be excluded. However for the event of inappropriate schedule of Product administration for  mRNA-1273, causality is assessed as not applicable
Symptoms: Nauseous, Light headed VS: BP 115/50 RR - 18 Intervention: Water and granola bar
as soon as  got the shot he passed out , not responding , gave him epinephrine 0.3 mg auto injector, with in 5 minutes paramedics came and took care of him , he is fine, talking  good, , feeling ,  after few minutes he walked away with family member
fever; nausea; This case was reported by a consumer and described the occurrence of fever in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th December 2020, the patient received the 1st dose of Shingrix. On 15th December 2020, 1 days after receiving Shingrix, the patient experienced fever and nausea. On an unknown date, the outcome of the fever and nausea were not recovered/not resolved.   It was unknown if the reporter considered the fever and nausea to be related to Shingrix.  Additional information was provided as follows: The case was reported by patient's sister. The next day of receiving vaccine, the patient reported experiencing nausea and a fever. The reporter was asking for medical advice on how to treat the symptom and did not have time to do a report. The reporter did not consent to follow-up.
Fever, body ache, nausea, vomiting, eyes feel hot, head hurts, diarrhea,  I gave him 500mg Tylenol
The vial was initially stored in the refrigerator from the freezer on 27-Apr-2022 and the doses were administered on 28-May-2022.; administered with vaccine that is past beyond the 30 day use; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator from the freezer on 27-Apr-2022 and the doses were administered on 28-May-2022.) and EXPIRED PRODUCT ADMINISTERED (administered with vaccine that is past beyond the 30 day use) in a 61-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 056M21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Janssen on 24-Mar-2021 and Pfizer on 18-Dec-2021. Past adverse reactions to the above products included No adverse event with Janssen and Pfizer.    On 28-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with vaccine that is past beyond the 30 day use). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator from the freezer on 27-Apr-2022 and the doses were administered on 28-May-2022.). At the time of the report, PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator from the freezer on 27-Apr-2022 and the doses were administered on 28-May-2022.) and EXPIRED PRODUCT ADMINISTERED (administered with vaccine that is past beyond the 30 day use) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The vial was initially stored in the refrigerator from the freezer on 27-Apr-2022 and the doses were administered on 28-May-2022. No treatment medications were reported.   This case was linked to MOD-2022-581520 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2022: Follow up received on 01/Jun/2022: Upon follow up the case was upgraded to valid from invalid. added patient initials, date of birth, added historical vaccine, updated suspect coding and added event of product storage error which was missed in previous version.
Pt immediately developed swelling at injections site even before needle was completely removed. Instantly became hot to the touch, sweated profusely and felt "woozy".  He refused the Benadryl injection and a 911 call as he was a retired EMT and felt it would just pass.  He stayed here for 45 minutes and regained color and equalibrium and ceased sweating. Swelling remained but was more diffuse than at time of injection. I gave a follow up call at 5 pm and he said swelling was still there and he felt as if he was running a low grade fever but was at work.
lot of pain all the time; they feel heat; it is hard to walk and their knees are locked; and their knees are locked  and it is all worse at night; Their eyes are very dry; their lips are tingling andpuffed and also their fingers, toes, legs, hands and face pinches like needles that make her scream and even in their vagina; everything is swollen and tight; lips are tingling and puffed; Patient states everything is swollen and tight.; soreness all the time; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (lot of pain all the time), FEELING HOT (they feel heat), GAIT DISTURBANCE (it is hard to walk and their knees are locked), JOINT LOCK (and their knees are locked  and it is all worse at night) and DRY EYE (Their eyes are very dry) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    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, the patient experienced PAIN (lot of pain all the time), FEELING HOT (they feel heat), GAIT DISTURBANCE (it is hard to walk and their knees are locked), JOINT LOCK (and their knees are locked  and it is all worse at night), DRY EYE (Their eyes are very dry), PARAESTHESIA (their lips are tingling andpuffed and also their fingers, toes, legs, hands and face pinches like needles that make her scream and even in their vagina), SWELLING (everything is swollen and tight), LIP SWELLING (lips are tingling and puffed), MUSCLE TIGHTNESS (Patient states everything is swollen and tight.) and MYALGIA (soreness all the time). At the time of the report, PAIN (lot of pain all the time), FEELING HOT (they feel heat), GAIT DISTURBANCE (it is hard to walk and their knees are locked), JOINT LOCK (and their knees are locked  and it is all worse at night), DRY EYE (Their eyes are very dry), PARAESTHESIA (their lips are tingling andpuffed and also their fingers, toes, legs, hands and face pinches like needles that make her scream and even in their vagina), SWELLING (everything is swollen and tight), LIP SWELLING (lips are tingling and puffed), MUSCLE TIGHTNESS (Patient states everything is swollen and tight.) and MYALGIA (soreness all the time) outcome was unknown.            No concomitant medications reported. No treatment information was provided.
Presented with syncopal episode after falling ill with malaise; he developed cough and had poor oral intake and experienced a syncopal event and came into the ED where he tested positive for COVID. Chest Xray showed an possible infiltrate on the left side, he did not require supplemental O2.  Tx w/abx, Remdesivir, Vit D3, Vit C, zinc; dc'd home.
Pt hospitalized for COVID19 on 6/30/2021.  Has had 1 week of SOB.  Tested negative on 6/28 at PCP office.  His shortness of breath started getting worse since then associated with dry cough, loss of appetite and nausea. Denies fever, chills and abdominal pain. Denies recent sick contact.  Tested positive for COVID19 on 6/30/21
Within a minute of administration child developed local allergic reaction. Large red area with mild swelling, pain. BENADRYL po given and soreness dissipated within 1/2 hr left clinic with mild erythema.
Within 15 minutes of the administration of the 2nd dose of the vaccine, patient experienced dyspnea accompanied with sensation of throat tightness. Appeared as though patient was also suffering from sense of impending doom.
Hives, itchiness, swollen and itchy tongue/lips, mild wheezing. I took zyrtec before I noticed symptoms beginning, which probably helped. The next day, as the zyrtec started to wear off, my tongue/lips began to feel itchy and mildly swollen again. I called my doctor but did not go to the hospital
2 days after 2nd vaccination, felt dizzy; Short of breath; Fatigue; Right arm weakness; Picking up or opening anything feel weakness and shoots up to where shot was given; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 27Apr2021 at 15:00 (at the age of 52-year-old) as dose 2, single for COVID-19 immunisation. Medical history included hemiparesis (left) and spasticity. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) and botulinum toxin type a (BOTOX) from unknown date for unspecified indication. The patient has taken AVELOX on an unknown date and experienced allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date for COVID-19 immunisation. On 29Apr2021 at 12:00, 2 days after vaccination, the patient felt dizzy, short of breath, fatigue, right arm weak. While picking up or opening anything, the patient felt weakness and shoots up to where shot was given, the symptoms were ongoing at the time of this report. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events which included treatment with steroids. The outcome of the events 2 days after 2nd vaccination, felt dizzy, short of breath, fatigue, right arm weakness, picking up or opening anything feel weakness and shoots up to where shot was given was not recovered at the time of this report.  Information on the lot/batch number not available, despite of follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
PT fainted right after vaccinated while in chair, immediately  awake within minute. Paramedic came , hydrate, symptoms resolved, refused hospital transportation, driven home by mother
Patient developed redness, swelling and itching to right upper outer arm and painful to touch on 12/20/15. The redness, swelling and itching improved, however, was still present on 12/21/15. Patient seen in office visit on 12/21/15. Patient had been applying ice and cortisone cream at onset. This treatment and BENADRYL was recommended at MD visit.
pt recv vax 18DEC96 & lab eval revealed a lack of response for varicella;pt also did not seroconvert p/vax;
mom reports that pt was in an automobile accident 2 hrs post vax; states that felt timid p/shot, ate lunch & drove to work; father states drove through a red light & had been observed by witnesses to be driving eratically;
Pt was given immunizations, went home, dad called 4-8-10 in afternoon to report red and warm. Told to use MOTRIN or TYLENOL. Returned call on 4-9-10 and redness going away.
On 1/11/01, pt ran a temperature of 101F, shivering, sweating and dizziness. On 1/14/01, other symptoms decreasing except dizziness. That AM had stomach cramps but no nausea, vomiting or diarrhea noted. On 1/16/01, cramps and dizziness remain but have decreased. Referred to pt's MD. Pt feels no need, as symptoms are resolving. I stated for pt to call if he decides on MD follow-up.
PATIENT WAS FILLING DIZZY AT FIRST AND THEN HER HEART RATE WAS ELEVATING TO 150
March 5th it was discovered that I had a blood clot in right lung. Treated with Xeralto blood thinner. Still using. On April 23rd, I was diagnosed with shingles on the right side of torso. Treated with steroids and pain med.
Since I had a reaction to my first Vx where my BP climbed to 150, the center was concerned about my well being, so they had an EMT sit with me to watch my vitals. I ended up going through the exact same thing as before. I felt dizzy and lightheaded and my BP climbed to 150. I felt a straining in my neck, but I could breathe just fine. They recommended that I go to the ER in an ambulance, but I refused and promised that I would go to the hospital myself if I started feeling worse.
Patient is reporting feeling weak, dizziness, a bruise on left arm (vaccine site), having swollen and inflamed ears one day after taking the vaccine.  These sides effects are continuing even a week after.