chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient fainted after receiving immunizations. 0840 At the initial assessment before immunizing mother stated that the patient has no history of fainting in the past and the patient had breakfast this morning. At or about 0843, the patient was administered the following vaccines: TDAP, MMR, VARICELLA, IPV. Upon completion, patient moved out of vaccination chair to another chair for observation. At or about 0848, we observed patient loss of consciousness with present jerky motions that lasted 2 or 3 seconds leaning and sliding her down to the wall. Patient's mother grabbed and held patient after she reached the floor and then stayed with her on the floor. After this episode, patient was fully awake. Had patient lay down and her feet were elevated. Patient was questioned by the Staff Nurse to see if she was injured. Patient was then given full assessment to ensure there were no injuries. Patient was found to have no injuries. Patient denies headache, nausea, or any other discomfort. After ensuring patient was stable, patient was ok to leave accompanied by her mother. Instructed mother to observe patient for any change on patient condition, if occurs then take the patient to the Emergency Room. Patient left the clinic accompanied by mother at 0930. 11:42 Staff Nurse called to check on condition of the patient and was told by mother that patient was doing good and had just finished eating. Mother was given telephone number of clinic and was told that we will call again later to check on patient and if any problems arise to get patient to the nearest Emergency Room. At 15:05 Staff Nurse called to check on patient again and mother stated daughter feels great. PHN Manager was informed of the situation.
Lost hearing in his right ear; Partial hearing in his left ear; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS UNILATERAL (Lost hearing in his right ear) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jun-2021, the patient experienced DEAFNESS UNILATERAL (Lost hearing in his right ear) (seriousness criterion medically significant) and HYPOACUSIS (Partial hearing in his left ear). At the time of the report, DEAFNESS UNILATERAL (Lost hearing in his right ear) and HYPOACUSIS (Partial hearing in his left ear) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medications and treatment details were not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded; 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, a causal relationship cannot be excluded
I was tired and fell asleep at around 9pm and woke up around 2am; I went to go take a shower and once I got in, I had extreme chills; I couldn't breathe and I felt like my lungs were flaring up, and Iimmediately got out of the shower.; This is a spontaneous report from a contactable consumer (patient). 22-year-old-male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration in left arm on 17Mar2021 02:00 PM at single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. No other vaccines was administered within 4 weeks prior to the COVID vaccine. It was reported that patient was fine the day of the vaccine. On 17Mar2021, that night, he was tired and fell asleep at around 9pm and woke up around 2am. He went to go take a shower and once he got in, he had extreme chills and he couldn't breathe and he felt like his lungs were flaring up, and he immediately got out of the shower. Two weeks later, it happened exactly the same way even though he was fine for the weeks between. There was no treatment received for the adverse event. The outcome of the events was recovering.   No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Could not smell anything; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (Could not smell anything) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 028L20A) for COVID-19 vaccination.     No medical history was not provided by reporter.  Concomitant products included LEVOTHYROXINE SODIUM (LEVOTHYROXIN) for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ANOSMIA (Could not smell anything). At the time of the report, ANOSMIA (Could not smell anything) outcome was unknown.
Right arm pneumonia vaccine left arm influenza vaccine given. Next day right arm had bruise and bruising continued down the arm. Saw pt on 11/4/02 at another clinic and talked with client and referred to Dr. Had bleeding time completed at Dr office and was taken off Coumadine for three days.
1 week after vaccine( 1/21/21), injection site presented red, swollen, itchy, warm and tender to touch. Site grew in size and tripled in 3 days, documented with pictures. Medical care sought 1/23/21. Diagnosis: Cellulitis of upper left limb; Treatment :10 days of Cephalexin 250mg and 6 days of Methylprednisolone 4mg. Outcome: At time of report, 1 day later from seeking medical care, site has reduced in size. Still warm and itching.
Purple Palms - 2 pm Fri. - Ventolin MDI - SOB 2 puffs x 1 @ 3 pm Sat. a.m. - 8 AM - Nausea, - V-8 T - 101 - p.m. - Flu Symptoms, Advil 200 mg x 2, sweating, H/A, Erythema - Diffuse - (L) Side Neck Sun. - T - 100 Mon. - T - 99.2 Hx - Varicella - Internally Presented with this Reaction 24 hrs. post-vaccination Erythema + Edema at Injection site Shingrix arm 65 mm W x 30 mm L PCV 13 arm 60 mm W x 40 mmL Fever - 101 degrees F oral, Diffuse erythema on (L) side of neck down shoulders + (L) UA. @2 hrs. post vaccination - Palms of both hands - purple. Took 2 puffs MDI - Sx Resolved.
Mom noticed just prior to contacting PHN that right upper arm is red, warm and swollen, Child denies discomfort, No treatment ,  PHN instructed mom to call family  doctor now.
Vaccines given on 3/21/21. Fever and fatigue so was in bed x 1 1/2 days. Awoke next am with calf pain and swelling.  Seen 3/30/21 and OS performed 3/31 with Left lower extremely DUT. Now on Xarelto for minimum 3 months.
First 15 minutes no reaction and I left.  About 15 minutes later tongue began to experience pain.  Left side, tongue had approximately 3 cysts trying to come out.  Left side of tongue became swollen.  Was in pain for about an few hours.  Could feel the lumps but hard to spot.  Saw one once I was at home and I could inspect.  Mouth was sore that evening but pain was finally gone.
FEVER ONSET 3/23/07 WITH TEMP 104'.  NO OTHER SYMPTOMS, ONLY CUTTING TEETH.  APPETITE GOOD, NO VOMITING OR DIARRHEA.  TREATED WITH MOTRIN AND TYLENOL.
patient is fully vaccinated (Pfizer, 3/27/21; 4/17/21) and developed a sore throat on 7/24/21, after exposure on 7/21/21
Immediately, his arm turned bright red and his hand went numb.; swollen and red lump at the injection site; Immediately, his arm turned bright red and his hand went numb; swollen and red lump at the injection site; swollen and red lump at the injection site; my left arm at the injection site looks as if someone cut a grape fruit in half and stuck it on the side; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Immediately, his arm turned bright red and his hand went numb.), VACCINATION SITE MASS (swollen and red lump at the injection site), HYPOAESTHESIA (Immediately, his arm turned bright red and his hand went numb), VACCINATION SITE ERYTHEMA (swollen and red lump at the injection site) and VACCINATION SITE SWELLING (swollen and red lump at the injection site) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-May-2021, the patient experienced ERYTHEMA (Immediately, his arm turned bright red and his hand went numb.), VACCINATION SITE MASS (swollen and red lump at the injection site), HYPOAESTHESIA (Immediately, his arm turned bright red and his hand went numb), VACCINATION SITE ERYTHEMA (swollen and red lump at the injection site), VACCINATION SITE SWELLING (swollen and red lump at the injection site) and VACCINATION SITE REACTION (my left arm at the injection site looks as if someone cut a grape fruit in half and stuck it on the side). At the time of the report, ERYTHEMA (Immediately, his arm turned bright red and his hand went numb.), VACCINATION SITE MASS (swollen and red lump at the injection site), HYPOAESTHESIA (Immediately, his arm turned bright red and his hand went numb), VACCINATION SITE ERYTHEMA (swollen and red lump at the injection site), VACCINATION SITE SWELLING (swollen and red lump at the injection site) and VACCINATION SITE REACTION (my left arm at the injection site looks as if someone cut a grape fruit in half and stuck it on the side) outcome was unknown. Not Provided          No concomitant medication was reported. Treatment medication was not provided.
Patient admitted to hospital on 11/30/2021 with positive COVID test Requiring ICU admission, heated high flow oxygen and high fio2 requirements
Expired Engerix B administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received HBV (Engerix B) (batch number unknown, expiry date 30th September 2022) for prophylaxis.   On 13th October 2022, the patient received Engerix B. On 13th October 2022, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 13-Oct-2022 Reporter's comment: The pharmacist did not had information about gender, initials or date of birth for the patient, or information about Engerix-B lot number. The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Engerix-B, which led to expired vaccine used.
Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Headache-Medium, Additional Details: In addition to above, pt also complained of an "ache that went all the way into her hand" on the arm that was immunized (right).
2 days since getting the booster I have been having high heart rate and atrial fibrillation episodes everyday. The cardiologist suspects that when me and my husband caught Covid last year that that's what started our heart issues. Since getting the vaccine my A-fib has gotten worse. I am working with my cardiologist to see what's causing my A-fib.
This spontaneous report was received from a company representative, who was reporting on his mother-in-law, a 71-year-old female patient. The patient's concurrent condition included fibromyalgia and arthritis. Her drug reaction and allergies were unknown. On an unknown date, the patient was vaccinated with ZOSTAVAX for prevention (dose, route of administration, anatomical location, lot# and expiration date were not reported). Other suspect therapies included sterile diluent (STERILE DILUENT) (dose, frequency, route of administration, lot# and expiration date were not reported). Concomitant therapies were not provided. On an unknown date, also reported as "beginning on an unspecified date and received on 08-MAY-2018; discrepancy", the patient developed discomfort, itching, rash on the right chest cavity, and no pain. The patient sought medical attention and on 8-MAY-2018 was diagnosed with shingles. On an unspecified date, the patient received something to help with the symptoms (details were not reported). Product quality complaint was not reported. The outcome of the event was reported as not recovered. Causality assessment was not provided.
Information has been received from via the physician of a patient whose mother found the current case online. The current case concerns a female patient who on an unspecified date was vaccinated with a dose of GARDASIL. The mother of the other patient stated that the current patient had the "exact same problem" as her daughter: minor localized tenderness, developed a rash, dysarthria without other seizure symptoms, had loss of consciousness, complained of numbness and tingling, pain in side, burning pain, paralysis and stroke-like symptoms. The patient sought a specialist. Attempts are being made to verify the existence of an identifiable patient and reporter. Upon internal review, paralysis and stroke-like symptoms were considered to be other important medical events. This is one of several cases from the same source. Additional information has been requested.  06/04/09 Neurology received DOS 7/24/09 to 9/18/07. FINAL DIAGNOSIS: Chronic inflammatory demyelinating polyradiculoneuropathy. Post vaccination complained of bilateral distal lower extremity numbness, began in toes then spread proximally. Later numbness in fingers. Weakness when climbing stairs. Areflexia, diminshed strength all 4 extremities. Normal sensory exam. + Romberg. IVIg administered.  5/26/09 Received PCP medical records of 7/23/07-8/6/07 including hospital d/c summary for 7/24-7/29/2007 admission. FINAL DX: acute Guillain-barre syndrome; hyperlipidemia; weakness of RUE & bilateral feet. Records reveal when patient seen on 7/23 experienced tingling/burning/numbness of extremities, loss of muscle control in legs, incoordination, difficulty walking x 1 wk, & 2 wks after HPV & MCV4 given.  Admitted to hospital.  Neuro consult done & tx w/IVIG.  On 8/6 visit had improved & continued Neuro f/u.  EMG done 9/10/07 revealed worsening demyelination & axonal loss c/w CIDP.  recommended repeat tx w/IVIG.
Constant pressure in forehead; no throbbing or pain. Occasional loss of appetite.  Started about 2 weeks after second dose of Moderna and has continued.
Pt recvd Engerix-B & had dizziness, lightheadedness; sx subsided in 3 hrs p/onset;
No Immediate effect. Not sure if events are related ! On March 24th 2021, patient received the one Janssen # 1805022 Covid vaccine, at home, from a at Home doctor.  1) On May 12th 2021, patient, at home on the vent, began getting tired, she threw up, could barely walk and eventually became totally lethargic. Her oxygen was low and the on hand nurse used the Ambu bag to get her oxygen up to 100, while I called the ENT?s. The ENT?s checked her vitals, and did an EKG. We spoke to the doctor, and although by that time she was acting somewhat ?normal?, the decision was made to take her to hospital. Her oxygen was stabilized and her CO2 at the hospital was 80. She remained in the hospital for four days.  2) On Sunday, July 4th, patient was at home on the ventilator.   Approximately 1:30 pm she seemed to become somewhat tired and she dropped her coffee cup.A little later, while eating, she threw up, spilling food and drink on her top. She seemed more tired and needed help changing her top. She sat in her recliner for a while and then she had to go to the bathroom. I took her there in a wheelchair. By the time she was ready to leave the bathroom, she was comatose and I had to lift her, she was dead weight, and place her in the wheelchair.  I rolled her to the recliner and lifted her into it.  She was then completely unconscious, with a continuously running nose and bubbles and fluid coming from her mouth ! Note: This was exactly same experience we had with her on May  12th 2021, when she was taken to hospital.   I increased her breath rate on the Vent from 16 to 20, hoping that would expel CO2. I also increased the oxygen setting on the floor concentrator to 9, her pulse oxy was stable at 90. With the help of my daughter in law and grandson, we repositioned her on the recliner to a more comfortable and accessible position, connected the AMBU bag to the oxygen and slowly applied oxygen through her trach connection.  We had also called the emergency, requesting assistance. By slowly squeezing the AMBU bag, I got her oxygen up to 100 ! Note: This Is exactly what we did on May 12 th.  The ENT?s arrived shortly and within a few minutes after they arrived, patient started to come out of her comatose condition. The ENT?s checked her vitals,(somewhat normal) did an EKG, and checked her CO2 (45).We spoke to the doctor, and by that time she was acting ?normal? ! The decision was made to keep her at home instead of going to the hospital and an at-home X-ray was ordered in case she aspirated and conducted the following day. This x-ray Did Not show any aspiration !
feeling generally weak, slid out of bed while trying to get up and use her walker, landed on the floor, sat there for several hours, not wanting to disturb her family. Did not hit her head, no LOC. Did not feel "hurt", other than a scratch on her left hand, but had a hard time getting up on her own.    She was diagnosed with a urinary tract infection as an outpatient and was started on Duricef yesterday.  Denies fevers or chills. She has a nonproductive cough, can hear herself wheezing, states this isn't normal for her. No chest pain, no difficulty breathing.
starting 30-45 minutes after injection, my right eye started twitching.  By evening, I had mild flu symptoms and a sore arm that lasted for 24 hrs.  One week later, my eye is still twitching numerous times daily and I am getting off and on headaches.
itching palms and soles; erythematic rash / eruption; tongue swelling; This case was reported by a physician via call center representative and described the occurrence of pruritus in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included sulfonamide allergy (allergic reactions to sulfa drugs).   On 4th March 2020, the patient received the 1st dose of Shingrix. On 4th March 2020, less than a day after receiving Shingrix, the patient experienced pruritus, red rash and swollen tongue. On an unknown date, the outcome of the pruritus, red rash and swollen tongue were not recovered/not resolved.   It was unknown if the reporter considered the pruritus, red rash and swollen tongue to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was captured as an adult as per vaccine indication. The patient started experiencing itching palms and soles, erythema rash, tongue swelling. The patient was treated in the emergency room. Eruption was ongoing at the time of reporting.
Heart pounded heavily starting at 10PM preventing sleep. Continued until 3AM (April 29, when medics arrived). Right side of face flushed. Front of thighs very flushed.  Called 911.  Medics measured blood pressure at 182/81.  BP had always been normal (120/60 or less).  Pulse = 84. BP lowered to c. 164/?? while medics were with patient.  Patient saw her doctor a few days later.  Metoprolol prescribed; started May 12 @25 mg with dosage increased to 100mg  over three weeks.  BLOOD PRESSURE REMAINS ELEVATED DESPITE MEDICATION 100mg daily.  BP ranges erratically 184/81 to 134/66 on medication.  BP HAS NOT RETURNED TO NORMAL.
Diarrhea; vomiting; High temperature; Head aches; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), VOMITING (vomiting), PYREXIA (High temperature) and HEADACHE (Head aches) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hepatitis B. Concomitant products included ENTECAVIR (BARACLUDE) for Hepatitis B, LOVASTATIN and ENTECAVIR for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced HEADACHE (Head aches). On 29-Jan-2021, the patient experienced DIARRHOEA (Diarrhea), VOMITING (vomiting) and PYREXIA (High temperature). At the time of the report, DIARRHOEA (Diarrhea), VOMITING (vomiting), PYREXIA (High temperature) and HEADACHE (Head aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) °F.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Follow-up information received on 25 Jun 2021 contains no new information.
Mildly swollen, is warm to the touch to below the elbow and there is redness present around the injection site and slightly below (2 inches) with area of induration. Patient has been complaining that his arm hurts, has been guarding arm since the injection and feels his arm hurts most with extension or movement. Patient is not reporting pain now. Patient denies SOB, or other systematic complaints.
Information has been received from a nurse referring to unspecified patients of unknown age and gender. Information about patients' concurrent conditions and medical history was not reported. The nurse reported that 8 doses of improperly stored PROQUAD (Merck) (dose and route not reported, lot # K011312 with expiration date 14-FEB-2016) had been administered to the patients on unspecified dates. No adverse effects were reported. Additional information has been requested.
A report has been received from a Health Professional concerning a 5 year old, female subject, who had been receiving nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent started on 13-NOV-2014. It was reported that the patient was administered the vaccine wrongfully by a nurse which started on 13-NOV-2014. The outcome of the event of wrongful administration is unknown. The report was considered to be non-serious. The reporter and company physician considered that there was no casual relationship between wrongful administration and FLUMIST Quadrivalent.
Jansen covid-19 vaccine eua.  Can not feel left side of back neck shoulder. Shooting pain down arm to fingers. Burning sensation in back. Headache from neck area.
Dx: Varicella- rash,itching-Benadryl 12.5/5 3/4 tsp q 6 hours prn-Caladryl prn.
Exaxtly 1 week after shot, injection site stsrted itching like a mosquito bite with no bump.  I was showering when I noticed it, maybe hot water irritated it?  It continues to itch and the red xircle around it is a little bigger than a half dollar.  It sounds exactly like "covid arm".   No other side effects noticed at this time.