chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning a 41 year old female with a pcn allergy and ALP 46, AST 18.7 on 05/19/2000, who on 11/09/2000 was vaccinated with hep B vaccine recombinant IM in the left deltoid. On 12/05/2000 the pt was vaccinated again (second dose) with hep B vaccine recombinant IM in the left deltoid. On 01/03/2001 the pt donated blood and was told that her liver enzymes were elevated. In follow-up the physician reported that the liver enzymes on 05/19/2000 were normal. Follow-up info received from the pt revealed the blood donation lab results from 01/03/2001. Follow-up info from the same nurse indicated that on 05/31/2000 the pt had an abnormal mammogram. On 04/05/2001 the pt's GGT-37.1; ALT-41.1; bilirubin-.4, bilirubin total-.7; Alk phos-63.3; AST-31.1; and albumin-4.3. The reporter inquired as to whether the full hep B immunization series should be completed in this pt. Additional info is not expected.
16 hours after the second dose I awoke with chills, temp of 97.1, headache, unusual fatigue and weakness, no energy, redness, swelling and significant tenderness at the injection site.  These symptoms remained acute for 6 hours then started to abate.  By 2pm 3/2/2021 I was completely fine except that the injection site remained red and tender for another 24 hours.   This is the first time this is being reported.  I did not tell my HCP as I assumed the side effects would be temporary.  And they were.
Fast heart beat; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 42-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration, administered in Arm Left on 09Mar2021 14:45 (at the age of 42 years) as dose 1, single for COVID-19 immunization. The patient medical history included hypertension. Concomitant medication included nature made VITAMIN D [VITAMIN D NOS] and multi vitamin taken for an unspecified indication. Patient had no Known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient did not diagnose with COVID-19. Since the vaccination, did not patient been tested for COVID-19. Facility type vaccine: Hospital. The patient experienced fast heartbeat on 10Mar2021. The patient underwent lab tests and procedures which included heart rate: fast on 10Mar2021. The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Red area right thigh 3x2cm warm prev. reported x3 spots on buttocks on 06/03/02.
Pain and tenderness in upper left arm, radiating to neck and shoulders Feeling of being very cold, accompanied by severe shivering. Headache Letheragy Skin sensitivity to sunlight - sunburn in 30 minutes of sun exposure to head and face when areas were already well tanned.
Rash on body and face. Swollen cheeks. Itchy. Hives 1 hour after vaccines. Spread over groin. Went to face, trunk, arms, legs within 3 hours. Treated with BENADRYL and calamine lotion.
Patient presented on Monday 2/11 stating the day after receiving SHINGRIX she had mouth, lip, chin, and facial pain with raised bumps that she thought were shingles. I advised setting an appointment with primary care to have the rash evaluated.
grand mal sz, lasted about 3min, occurred about 8hr p/vax;pt was not febrile;pt is developmentally delayed & has had 2-3 prev sz;
Normal feel sick, weak after 2nd dose; for 2 days threw-up; 3rd day very weak; Felt pain in my bones; This is a spontaneous report from a contactable consumer (patient) reported in response to Non-HCP letter send in cross-reference case.   A 55-years-old patient of an unknown gender received second dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot number: not reported) administered in right arm via an unknown route of administration on 28May2021 at 11:15 as dose 2, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported.   The patient previously received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot number: ER8735) administered in upper right arm via an unknown route of administration on 01May2021 at 11:15 am and experienced no adverse event. On an unknown date, the patient experienced normal feel sick, weak after 2nd dose, for 2 days threw-up, 3rd day very weak and felt pain in my bones. It was reported that the patient was normal feel sick week after 2nd shot for 2days threw-up and on 3rd day very weak. The patient felt pain in the bones after 5 days was normal fine. The outcome of the events normal feel sick, weak after 2nd dose, for 2 days threw-up, 3rd day very weak was reported as unknown while the outcome of the event felt pain in my bones was reported as recovered on an unknown date in 2021. Follow up attempts are completed. No further information is expected.
Information has been received from a registered pharmacist reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions or medical history. The patient's concomitant medications included sterile diluent. On 29-JAN-2018, the patient received an improperly stored dose of ZOSTAVAX 19400 plaque-forming unit (PFU), lot # N021170, expiration date 27-OCT-2018 for prophylaxis (dose, anatomical location and route of administration were not reported). No adverse effects were reported. It was reported that on an unspecified date, the vaccine was exposed to a temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 2 hours and 30 minutes. The reporter stated that there was no previous temperature excursion. The call was placed because of a Digital Data logger report.
3y.o. patient who received a Quadracel inadvertantly on 15Nov2019; Initial information received on 12-Dec-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 3 years old male patient who received vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] and reported that 3y.o. patient who received a Quadracel inadvertantly on 15-Nov-2019 (product administered to patient of inappropriate age).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included INFLUENZA VACCINE INACT SPLIT VIRION 4V (FLUZONE QUADRIVALENT); and HEPATITIS B VACCINE (HEPATITIS B VACCINE).  On 15-Nov-2019, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot C5532AA and expiry date: 09-Oct-2020 via intramuscular route in the right thigh.  It was a case of actual medication error due to inappropriate age at vaccine administration.  It was not reported if any adverse event occurred or not.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
VARICELLA VACCINE WAS GIVEN IN L THIGH SHOWED A 5CM X 2.5 CM OVAL RED AREA, SLIGHTLY RAISED AREA THAT IS NOT HOT TO TOUCH, IT IS NOT FLUCTUANT. IT APPEARS TO BE SLIGHTLY UNCOMFORTABLE TO HIM WHEN AREA IS TOUCHED.
Fever, rash + vomiting started 6/15/19. Vomiting resolved by 6/17 and fever diminished though still with rash. Mild congestion.
Patient slumped in chair, and looked to possibly have a seizure.  Then 5 minutes later patient drooped head again.
Pt experienced redness and swelling to his left upper arm, extending down to just above the elbow (now 14 cm in length).  Pt assessed in the office on 9/11/2020.  Tissue around injection sites is soft, NO induration or swollen area noted.  NO drainage from injection sites.  Of note, Meningococcal vaccine was given 1 inch above the HPV9 vaccine.  The HPV9 vaccine did bleed slightly after injection due to patient tensing up.  RN did hold pressure to site until bleeding stopped on 9/8/2020 when vaccines are given.  Mother states that swelling to the left arm is better than initially noted on 9/9/2020 when she described it as baseball sized.     Mother states that the swelling started on the following day 9/9/2020 as noted in triage note from that day.  States that they've been using cold packs about 4 times daily as directed.  Patient DENIES pain, itching, or other symptoms in the arms.  Mother confirms that neither arm is bothering him.  With regard to right arm: Pt also received a Tdap to his right arm and there is splotchy redness to his upper right arm with some swelling.
Arm soreness; Chills; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   In October 2020, the patient received the 1st dose of Shingrix (intramuscular) and Influenza vaccine Quadrivalent 2020-2021 season. In October 2020, less than a day after receiving Shingrix and Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced pain in arm and chills. On an unknown date, the outcome of the pain in arm and chills were recovered/resolved.   It was unknown if the reporter considered the pain in arm and chills to be related to Shingrix and Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided as follows: The patient received 1st dose of Shingrix in unknown deltoid on 8th or 9th October 2020. The patient also received an unspecified flu shot that same day.  The patient stated that the Shingrix shot was given in one arm and the flu shot was given in the other arm.  The patient stated that the patient did had arm soreness in the arm where Shingrix was injected that night while sleeping she couldn't lay on that side.  The arm soreness did not last more than 24 hours, as she recalls. Also that night after receiving the Shingrix and Flu shot she did have chills but the chills were not so bad that they prevented her from being able to sleep. The chills resolved.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR247388:Same reporter. 2nd dose
100* fever for 1 day, lethargy for 5 days, brain fog for approximately 1 month, increased blood sugar - immediately after and still occurring. Severe cramping and abnormal bleeding, including the cycle lasting 12-14 days, during 2 menstrual cycles following vaccine. Inflammation and pain in joints, mostly in wrists- incapacitating pain. Inflammation in joints continues sporadically in various joints.
Large hives covered 85% of his body  Topical (Caladryl) Benadryl
For 7 weeks since the injection, the pt has noted pain and tenderness of the left deltoid diffusely and a very tender nodule inferiorly. Abduction of the shoulder is limited to 85 degrees actively and passively. Aspirin helps the pain a lot, she states.
COVID Arm:  Red patch around injection site.  Hot to the touch.  Tight and sore. Symptoms continue as of day 5 after vaccine administered.
1st vaccine on 2/20 and reported feeling "lousy" afterwards. On the evening of 2/23 felt like she was going to pass out. Felt worse when she woke the next morning. Presented to the ER on 2/24 with chest pain and "indigestion". Found to be in A.Fib with RVR. Vomited in ER triage. On 2/25 developed altered mental status, hypotension, hypoxemia. She was intubated and transferred to the ICU with severe lactic acidosis/shock/multiorgan failure. Had Right lower lobe infiltrate and right pleural effusion. Diagnosed with pneumonia and possible ischemic bowel.  Died on 2/26. Family requested autopsy.
The patient called on 03/05/2023 saying she got a vaccine at rite aid on 01/05/2023 and caused an infection at her left arm. She thought it would get better but it did not, She sought medical treatment on 03/09/2023. According to the patient, the doctor diagnosed her arm as being infected and prescribed antibiotic.
rash; hypersensitivity; Initial information received on 14-Jun-2019 regarding an unsolicited valid non-serious case received from a non-health care professional.  This case involves a male patient of unknown age who experienced rash and hypersensitivity, while he received vaccine RABIES (HDC) VACCINE [IMOVAX RABIES].  The patient's past vaccination(s) included 5 doses of Imovax Rabies for post exposure immunization also received immunosuppressant. The patient's past medical history, medical treatment(s) and family history were not provided.   On unknown dates two years ago, the patient received a sixth and seventh doses of suspect RABIES (HDC) VACCINE lot number not reported via unknown route in unknown administration site.  On unknown dates, the patient developed rash and hypersensitivity following the administration of RABIES (HDC) VACCINE. details of lab data not reported.  Final diagnosis was hypersensitivity and rash.   It was not reported if the patient received any corrective treatment.  At the time of reporting, event outcome was not reported.  There will be no information available on the batch number for this case.  List of documents held by sender: none.
Pt well at wellness visit 4pm 10/23/17 - about 0200 10/24/17 woke up with temp 103, headache, chills and dizziness. Vomited after Motrin. Restless through the rest of night and woke up in the morning with temp  103, headache, dizziness but no chills. Vomited after Tylenol. Spoke to Dad at 1:45 pm still with headache, dizziness and fever, no chills. Sipping fluids, no more vomiting. Appointment set with Dr. at 4pm today 10/24/17. Rapid Flu negative, mild acute distress, hepatomegaly - liver span 2 cm below costal margin. Lab test - CDCD, CMP, CRP, ESR. CRP elevated, LFT elevated. 10/25/17 - went to ED. REpeat labs and abdominal US done in ED. Observation and discharged home.
skip the 2nd dose and consequently did not receive it; 2 weeks later started to have different feeling; no energy; out of breath; sleepy during daytime; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (2 weeks later started to have different feeling), ASTHENIA (no energy), DYSPNOEA (out of breath), SOMNOLENCE (sleepy during daytime) and PRODUCT DOSE OMISSION ISSUE (skip the 2nd dose and consequently did not receive it) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN and FISH OIL (OMEGA 3 [FISH OIL]) for Cholesterol, HYDROCODONE for Pain, VITAMIN D NOS for Vitamin D deficiency.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced FEELING ABNORMAL (2 weeks later started to have different feeling), ASTHENIA (no energy), DYSPNOEA (out of breath) and SOMNOLENCE (sleepy during daytime). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (skip the 2nd dose and consequently did not receive it). At the time of the report, FEELING ABNORMAL (2 weeks later started to have different feeling), ASTHENIA (no energy), DYSPNOEA (out of breath) and SOMNOLENCE (sleepy during daytime) had not resolved and PRODUCT DOSE OMISSION ISSUE (skip the 2nd dose and consequently did not receive it) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.
8 hours after injection, I experienced severe diarrhea lasting about an hour. Fever peaked at 102 on day 1, day 2 fever was 99- 101, day 3 fever 99, no fever after day 4.  Chills and body aches sever day 1, moderate day 2, resolving by day 3.  Headache was severe on day 1 but tapered off through day 3.  Fatigue was extreme until day 3, but rapidly tapered off through days 4 to 6.
Syncope episode immediately after vaccination briefly lost consciousness and then woke up. Vitals were stable and she rested for 30 minutes and was able to walk out on her own.
At 1430 after receiving the Moderna Vaccine the previous day at 0930, my top lip began to tingle and feel swollen.  When I looked in the mirror,  my eyes also were swollen.  I contacted my PCP who recommended me come in for a clinic visit.  During my clinic visit, my physician noted increased unilateral swelling to the left side of my face with increased tingling and numbness by that point spreading to my cheek and face on the left side.  While still having functional use of that side of my face, my physician prescribed two different antihistamines as well as increasing another of my medications.  I was diagnosed with unilateral facial paralysis to the left side.  as of 9/23/21 at 1542, I am still having tingling to the left side of my face with occasional numbness feeling although most of the numbness has corrected itself.  Severe headaches over into my left ear and jaw continue however especially upon rising.
Unable to move arm the day after. Had to get help getting dressed.  Tingling feeling in arm, similar to how a body part feels if it had fallen "asleep".   Tingling feeling ended March 2nd. Arm still feels tender.
Patient developed an itchy rash to chest and abdomen. Mom says that rash looks like hives.
I began feeling poorly on Saturday.  I was achy and not sleeping well.  Sunday I had a terrible headache in the right side of my head and began to break out in a rash on the right side of my face.  By Monday, I was nauseous, had a terrible headache and the rash was getting worse.  I had at least 5 spots on my face where I was breaking out.  The sores were large and hurt.  They didn't really itch, it was more painful than itchy.
Weak, tired, shaky, nose running that evening. Slightly sore throat. Oct. 13: Fever was 101.8, vomited, weak, shaky, flushed face, nose running, lungs very congested and noisy, cannot clear mucus out of them. Very short of breath, on oxygen 4 lpm. at home. Multiple bowel movements that night. Oct. 14: Fever 100.4, face flushed and swollen, vomited twice by 5 p.m. Cannot keep food or liquids (soup, Ensure) down. Second vomit: bile. Weak, shaky, lungs very congested, cannot cough out mucus, wheezing, short of breath.
I am not sure what tdap I took , 12 hours after takin vaccines i have been experiencing severe aches, fevers with rigors, nausea, poor appetite
now she cannot lift her arm; she cannot sleep; experienced soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (now she cannot lift her arm), SLEEP DISORDER (she cannot sleep) and VACCINATION SITE PAIN (experienced soreness at the injection site) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21F) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure and Acid reflux (esophageal). Concomitant products included TRAZODONE for an unknown indication.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, the patient experienced LIMB DISCOMFORT (now she cannot lift her arm), SLEEP DISORDER (she cannot sleep) and VACCINATION SITE PAIN (experienced soreness at the injection site). At the time of the report, LIMB DISCOMFORT (now she cannot lift her arm), SLEEP DISORDER (she cannot sleep) and VACCINATION SITE PAIN (experienced soreness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  Additional treatment information included antihypertensive medication, acid reflux medication and SSRI medication.  Patient stated that she has an appointment with her nurse practitioner tomorrow (25May2021).
Tinnitus. Concurrent UTIs. Migraines lasting 7 days or more.
pt recvd vax & next day had mild feb sz; t 102; tx at home w/ apap & ibuprrofen;
Fever 101; Chills; Muscle soreness; Weakness; Intense headache; Growing pain in an area that previously had surgery on (in left clavicle); This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0196) via an unspecified route of administration in the left arm on 07Jul2021 at 13:00 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history included surgery in left clavicle. The patient had mild allergy to fruits. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0196) via an unspecified route of administration in the left arm on 17Jun2021 at 12:30 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 08Jul2021 at 00:45, the patient experienced fever 101, chills, muscle soreness, weakness, intense headache and growing pain in an area that she previously had surgery on (in her left clavicle). Om 08Jul2021 at 00:45 the patient underwent test which include body temperature and the result was 101 (unspecified units).The events did not result in doctor or other healthcare professional office/clinic visit, and 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 fever 101, chills, muscle soreness, weakness, intense headache and growing pain in an area that previously had surgery on (in left clavicle) were not resolved at the time of this report.
Abrupt onset of purely sensory neuropathy in tibial nerve distribution bilaterally in legs. Subsequent development a week later of purely sensory neuropathy in both arms and hands mainly in ulnar nerve distribution, and to a lesser extent median nerve distribution.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Headache-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Additional Details: 911 was called immediately.Parametics monitored patients BP and over all alertness at the store. Patient was adviced by the parametics to go to ER. Pt declined and had to sign AMA (against medical advice) form.
Patient had extremely enlarged lymph nodes in the crook of her neck. Her doctor told her it would subside with time. She was not given any medication for it.
pt w/in aobut 5-10 mins p/vax had tonic clonic sz w/some post ictal pallor & quietness noted; no focal findings noted on neurological exam; pt looking anxious;