chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hearing loss; infection on the left ear; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 58-year-old male patient received BNT162b2 (BNT162B2), on 04May2022 at 13:00 as dose 4 (booster), single (Lot number: FK9893) at the age of 58 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 3, Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 2, Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 1, Manufacturer: Unknown), for COVID-19 Immunization. Patient had no known allergies. The following information was reported: DEAFNESS (disability, medically significant) with onset 11May2022, outcome "recovered" (2022), described as "hearing loss"; EAR INFECTION (disability) with onset 11May2022, outcome "recovered" (2022), described as "infection on the left ear". Therapeutic measures were taken as a result of deafness. It was unknown if therapeutic measures were taken as a result of ear infection.  The clinical course was reported as: The patient had received other medications in 2 weeks. Patient received other vaccine in four weeks was unknown. Patient developed hearing loss and infection on the left ear about a week after receiving the vaccine. Patient recovered with lasting effects.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information provided there is a reasonable possibility of causal association between the events with the suspect product bnt162b2.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Around September 2021, I noticed two rashes the size of quarters on my elbows. It started to grow into the size of a hand grip on my arm. It started to leak a sap like substance at times and was very itchy. It has been keeping me awake. I have tried different creams. The Clinical Doctor provided me with two antibiotics. The sap like substance (thick and white) is gone, it's very sensitive to heat and still a bit itchy. I was told to cover up the areas if I go into public because it could spread easily, especially if it is leaking. I was out of work for a couple of weeks because of this. The itchiness feels like its spreading. I'm not able to stay out in the sun for too long, but that could be because of the antibiotics.
Redness, swelling to entire left upper arm from deltoid to elbow. Quickly started to resolve within 24-48 hrs. Also patient reported pain to left arm which resolved within 48 hrs.
This spontaneous report was received from a registered nurse and refers to a 48-year-old patient. No information on the patient's concurrent conditions, medical history and concomitant medications was reported. The reporter stated that on 23-OCT-2017, the patient received a pediatric dose of RECOMBIVAX HB 2.5/0.5 (units not provided), injection (lot #, expiration date, route of administration were not reported) for prophylaxis. No adverse effects were reported.
About 5 minutes after receiving vaccine pt became nauseated and sweaty. He than broke out in hives, All symptoms resolved after about one hour.
4x2inch infuriated painful swelling, pain, redness, warmth at injection site. Fever, muscle aches, chills, malaise starting around 8:30am 12/22 day after injection. Stayed in bed most of day. This was heterogenous booster. Received two dose series from Pfizer.
Patient developed shortness of breath approximately 10 minutes after vaccine administration. Patient received a dose of 0.3mL epinephrine IM 2 minutes later and was transported to the ED. VS in the ED were normal. Patient did not develop any other signs or symptoms of anaphylaxis. He was monitored for 1hr and discharged from the ED.
Information has been received from a nurse practitioner concerning a 6-month-old male who on 16-JAN-2007, 13-MAR-2007, and 15-MAY-2007 was vaccinated PO with the first, second, and third doses of Rotateq (Lot #'s 655407/1115F, 655407/1115F, and 656385/0030U, respectively). On 15-May-2007 the patient experienced a black tongue. It was noted that the mother was breastfeeding. The tongue was cultured on 11-JUN-2007 and stated that there was a "growth". The doctor referred the patient to the ENT specialist. The patient's black tongue persisted. No additional physician information was provided. There was no product quality complaint. Additional information has been requested.
Light sensitivity, irritation in the throat, continuous clear mucus from the nose, dry cough and then productive cough with yellowish mucus, headache, and the pain in the sinuses during the last two weeks. Tylenol, cold medicine.
Patient came to office with severe SOB, HA, dizziness, non-productive cough with chest pain upon coughing. Patient appeared very lethargic. Upon exam with doctor, patient was experiencing acute bronchospasms and a decrease O2 saturation of 92% dropping to 89% with ambulation. Medical records from physican's office included hospital records were reviewed. Final diagnosis with bilateral pneumonia. MD felt that the pt also had an allergic reaction to the Hep A vaccine. Follow up on 09/01/04: "Per telephone follow up with pt and vaccine provider. Vaccine was given at pt's employers location." Discharge Summary received on 12/07/2004 states final diagnoses were pneumonia vs allergic pneumonitis and asthma.
Pt states he had immediate redness, pain and swelling at time of the injection. By 10 PM the redness had spread over the back of his right arm, pt was unable to lay on arm due to pain and warmth.
Patient was non responsive with eyes open/lost consciousness at least 2 times.  The patient regained consciousness within a couple minutes.  The patient was sweating and felt cold.  We got him to the ground and gave him ice packs.  The patient stated they had not eaten anything so after he was starting to feel better we gave him food and water.   We  monitored the patient's blood pressure which was elevated but heart rate was normal.  We continued to monitor the patient until he was fully recovered and wanted to leave.
Flu like symptoms. Chills.  Stuffy head. Weak. Sore throat
No fever, vomiting, diarrhea. Pt just inconsolable crying for an hour.  Decreased feeding  still three days later.
Patient reports fever of 102 degrees F. beginning 12 hours post vaccination.  Patient reports malaise and sever headache began soon after fever.  Continuing until 54 hours post vaccination.  Patient referred to urgent care who referred patient to Hospital ED. Symptoms resolved by 09/18/2016.
Around June 2021 or July 2021 I had really bad allergies. I seen an allergist and got OTC allergy medication. I got a nose surgery over the summer because of a deviated septum I had. Late in the summer after my surgery I stopped taking my allergy medication. In September my hand and feet were starting to feel itchy. I woken up one day and it hurt to open my jaw. I could only open my mouth a little bit. I went to my PCP and she said it was possibly allergies so I started taken my allergy medications again. My hands and feet aren't as itchy anymore since taking the medications, but I still have some itchiness. I have never experienced this before.
Fever 102.4F (O). Pain and swelling left upper arm. No erythema, no injection site fever.
87-year-old patient with history of congestive heart failure. atrial fibrillation. hypertension. adrenal insufficiency secondary to hypopituitarism, breast cancer, coronary artery disease who has been having progressive weakness and shortness of breath over the past week. She has also been confused. History is mainly obtained from patient's son who 1s a physician's assistant, patient is currently on Bi PAP and not able to provide much history She was seen by her cardiologist Dr. about a week ago and her diuretics were decreased. She continued getting Aldactone and potassium Apparently her potassium levels were low at that time He denies any history of fever chills nausea vomiting she has had some loose stools lately about 2-3 times a day. Patient was finally convinced to come to the ER today where she was noticed to be hypothermic and hypotensive, temperature was 95.4 with blood pressure in the 80s systolic. Her son tells me that her temperature normally runs low around 96. Also blood pressure runs on the low side. She received 500 cc of normal saline bolus with some improvement in her blood pressure. 02 sats on initial presentation were documented as 79% on room air however I am not sure if these were acute right Per ER physician her sats were around 90 on room air and she was placed on 4 L due to dyspnea sats came up to 97%. Chest x-ray showed moderate left and small right pleural effusion with left lung base atelectasis versus pneumonitis, lactic acid level was elevated at 3.9, WBC count was 1.29, sodium was 150 and potassium 7.9 her creat1nine is 1 35 with BUN of 65. troponin was mildly elevated at 0 156 and B peptide was 24, 700. Her COVID screen came back positive, UA did not show any evidence of infection In the ER she received a dose of Vanco and Zosyn, 6 mg of IV dexamethasone. She received insulin D50 Kayexalate sodium bicarb and calcium gluconate for her hyperkalemia. And was placed on BiPAP
Pt developed pain, rash, fever evening of immuniz. rash progressed covering top arm and around tricep area, pt had fever...treated w/ antihist, compresses, much better, but still hurts as of 12-4-15.
At 20:30 (4 1/2 hours after Motrin dose), pt had a temperature of 103.3F and was fussy. He was breathing rapidly. After his next dose of Motrin at 22:00, the respiratory rate decreased and he fell asleep. He had 1 more fever to 103F (tympanic) about 23:00. OK the next AM.
A 25 y/o female nursing student contacted the DOH about a suspicious lesion on her chin. She had contact with her boyfriend, who is a contractor and was vaccinated against smallpox 4/26/11. The patient was with her boyfriend from May 4 through May 9 during which time the vaccinee only wore a band-aid on the site while they slept. She helped him change the bandage on his vaccination site on May 7 (site was red with central depression and purulent drainage). On May 9, the patient developed what she thought was a pimple on her chin. The lesion progressed and she recognized it as not being a pimple, and called the DOH on 5/11. On 5/13/11 she developed 3 additional lesions on her chin. She was treated with VIG on 5/14/11.
Provider orderer MMR-V (PROQUAD instead do MMR and VZV separatley (did not know PROQUAD is only approved up to age 12).
The vial was initially stored in the refrigerator from the freezer on 31-May-2022 and the doses were administered on 01-Jul-2022; Moderna vaccine administered beyond 30 day use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccine administered beyond 30 day use by date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator from the freezer on 31-May-2022 and the doses were administered on 01-Jul-2022) in a 79-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 054A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 01-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna vaccine administered beyond 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator from the freezer on 31-May-2022 and the doses were administered on 01-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna vaccine administered beyond 30 day use by date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator from the freezer on 31-May-2022 and the doses were administered on 01-Jul-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided by the reporter.  On 31-May-2022 at 4pm, The vial was initially stored in the refrigerator.   It was reported that moderna COVID 19 vaccine got a 30 day BUD out of the freezer and was administration of vaccine on 01-Jul-2022 between  9am and 12noon.   The vial did not undergo any temperature excursions.  No treatment medications was provided by the reporter.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received BNT162b2 (BNT162B2), on 19Oct2022 at 13:00 as dose number unknown, single (Lot number: FJ6739) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: High blood pressure; "hypothyroidism" (unspecified if ongoing); "pre-diabetic" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Levaquin, reaction(s): "known allergies: Levaquin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Dec2022) Negative; (25Dec2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient was treated for COVID-19 with anti-viral from 16Dec2022 to 21Dec2022. After recovering and testing negative on 22Dec2022, tested positive again on 25Dec2022.
Vaccine administered, approximately 30 minutes after vaccine administered clinic received call from patient's mother stating that patient was experiencing shortness of breath and chest pain that began approximately 15 minutes after administration of vaccination. Patient was advised to return to clinic, where vitals were taken and physical exam completed. VSS, patient endorsed pain with inspiration upon exam, but otherwise physical exam unremarkable. Symptoms stable after 30 minutes of observation without worsening. Patient advised to contact clinic if symptoms worsen or persist.
From ED Note: This is a 4-year-old female who was in her usual good state of health received the COVID-vaccine last Wednesday for 5 days ago and presents today with a new rash and rhinorrhea. She also started school this last week.  She is brought in now because starting today her father noticed a rash that was all the way from her neck to her knees, it was red, slightly raised, but did not seem to be itchy. She is otherwise acting completely normally despite the rhinorrhea she has no sore throat or congestion. She could have a rash related to the recent COVID-vaccine, she also have a rash associated with her rhinorrhea today and a mild viral infection. Nonetheless, it does not appear to be allergic in nature, there is no urticaria, it does not appear as an erythema multiforme type rash. She has no joint or muscle complaints. My diagnosis is of a morbilliform rash.
big bruise at injection site; some pain during the night; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (some pain during the night) and INJECTION SITE BRUISING (big bruise at injection site) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced PAIN (some pain during the night). On 02-Feb-2021, the patient experienced INJECTION SITE BRUISING (big bruise at injection site). At the time of the report, PAIN (some pain during the night) and INJECTION SITE BRUISING (big bruise at injection site) outcome was unknown. Not provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Products known to have been used by the patient were  medicines for high blood pressure, to help her urinate and for "palpitations" of the heart. No treatment information was provided.
Immediately following administration of flu vaccine I experienced severe pain in (L) shoulder and upper arm. Had extreme pain when trying to move shoulder for 3 days. Pain with limited range of motion still has not resolved as of 12/8/16.
within 24 hours: swelling in cheek on right side (occurred almost immediately: gave Benadryl and relatively resolved but had bumps on gums too now), ringing in right ear started, teeth started aching at same rate as heartbeat in the evening, knot on right forehead from veins (some relief in swelling but still sore), left thumb went numb   as of 11/2/2021: muscle spasms in right leg, nerve pain from inner right thigh (difficulty to walk), can "taste" vaccine, sweating and core temperature dropped, neck stiffness (unable to turn head), right eye vision distorted (patient is legally blind in right eye, but reports now being unable to see anything out of right eye), patient also reported not having any headaches since (she has had chronic headaches beforehand)
Complained of pain to left thigh and red. Triage done, seen by MD on 3/4-3/6 for ? viral GE.
he lifted a heavy object and tore the bicep distal tendon in that same (left) arm; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 20Apr2021 13:30 (Batch/Lot Number: EW0162) (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included cholesterol and spinal disc surgical repair in 2005. Concomitant medications included atorvastatin; cetirizine; aspirin [acetylsalicylic acid] (ASPIRIN), all were taken for an unspecified indication, start and stop date were not reported. The patient previously took codeine and experienced rash and wool-lanolin and experienced itch. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had not received other vaccine in four weeks. On 24Apr2021 18:00, four days after injection into his left arm, he lifted a heavy object and tore the bicep distal tendon in that same (left) arm which resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment for the event and surgical repair to be scheduled as soon as possible (ASAP). The outcome of event, he lifted a heavy object and tore the bicep distal tendon in that same (left) arm, was not recovered.  No follow-up attempts are needed. No further information is expected.
Patient / received the second dose / 1 week after receiving the first dose; This case was reported by a physician via call center representative and described the occurrence of drug dose administration interval too short in a patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included Men B NVS (Bexsero).   On an unknown date, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vacination was not reported. The physician reported that, the patient received dose 2, 1 week after 1st dose of Bexsero, which led to shortening of vaccination schedule. No further details were available as health care professional was hurry. The health care professional was provided with phone number to get in touch with them. The reporter consented to follow up.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 11-APR-2016, the patient was vaccinated with a dose of improperly stored VAQTA 25 U/0.5 ml, lot # L004743 with expiration date: 01-JUN-2017, via intramuscular route (dose was not reported). Administered dose of VAQTA underwent temperature excursion at 31.1 Fahrenheit degrees, for 82 hours. There was no previous temperature excursion. There was no adverse effect reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same source. Additional information has been requested.
Resident received second bivalent booster 11/29/2022 when taken out to see he primary care physician by POA. POA gave consent prior to facility to administer bivalent booster and Resident received booster 11/23/2022 at the facility. NP was made aware same day booster was given at Residents primary care doctors office. Resident had no adverse signs/symptoms following booster.
Miscarriage at 7 weeks in pregnancy. No other history of miscarriage and very sudden. Decidual cast.
Information has been received from a physician via a company representative referring to a patient of unknown age and gender. It was reported that the patient received "four or five" doses (not simultaneously) of GARDASIL over the course of several unspecified dates. No adverse effects reported. Additional information has been requested.
Patient had a sand dollar size lump form shortly after injection, and has had pain at injection site since. Has had difficulty moving arm. Vaccine may have been administered too high up on the shoulder. Patient following up with primary care md, will try to manage with over the counter treatment options.
GOT SHOT AROUND 9:45 AM. STARTING FEELING BAD AROUND 9 OR SO THAT NIGHT. WOKE UP ABOUT 2:00 AM WITH REALLY BAD CHILLS, HEAD HURTING REALLY BAD AND HURTING FROM HEAD TO TOES,  NAUSEATED. THAT LASTED ABOUT 24 HOURS. ARM WAS VERY SORE AND STILL TO THIS DAY IT HURTS AT DIFFERENT TIMES.