chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Had to go to hospital for a couple days and she got the flu; Initial information received on 02-Dec-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp.  This case involves an unknown age female patient who had to go to hospital for a couple days and she got the flu after receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received suspect influenza vaccine produced by unknown manufacturer (dose, strength, frequency, formulation, route, batch number, expiry date: unknown) in unknown administration site for prophylactic vaccination (immunization).  On an unknown date the patient diagnosed with serious event of had to go to hospital for a couple days and she got the flu (influenza) (unknown latency) following the administration of influenza vaccine.   No lab data was reported.  It was reported This case is received from Social Media. Be careful out there. My friend had the flu shot over a month ago. Had to go to hospital for a couple days and she GOT THE FLU. You still need the vaccine!  Action taken was not applicable.  It was not reported if the patient received a corrective treatment   At time of reporting, the outcome was Unknown   The patient was hospitalized for this event.; Sender's Comments: Sanofi Company Comment dated 07-Dec-2022: This case involves an unknown age female patient who had to go to hospital for a couple days and she got the flu after receiving vaccine influenza vaccine. Based on the limited information provided regarding this case, causal role of the company suspect product cannot be excluded. However, lack of information of past and concomitant medication, therapy details, any family history and any relevant medical history of patient, any concurrent conditions precludes comprehensive case assessment.
Information has been received from a registered nurse concerning a patient who on an unspecified date was vaccinated with a dose of Varivax instead of Zostavax due to "nurse error". There were no symptoms noted. There was no product quality complaint involved. Additional information has been requested.
48 hours later - secondary infection 2 large red "concentric circles" that are hot & indurated about 6cm each.
loss of sight and inability to speak.; loss of sight and inability to speak.; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21May2021 as dose 2, single (Lot number: EW0186) at the age of 38 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "anemia" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "dry eyes" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing); "gerd" (unspecified if ongoing); "arthritis" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing); "migraines" (unspecified if ongoing). Concomitant medication(s) included: HYDROCHLOROTHIAZIDE; MONTELUKAST; ADVAIR; NIFEDIPIN. Past drug history included: Amoxicillin, reaction(s): "known allergies: Amoxicillin". Vaccination history included: BNT162b2 (Dose 1, Single, Batch/lot number: EW0164, Anatomical Location: Left arm), administration date: 30Apr2021, for COVID-19 immunization. The following information was reported: BLINDNESS (hospitalization), MUTISM (hospitalization) all with onset 21Aug2021, outcome "not recovered" and all described as "loss of sight and inability to speak.". The patient was hospitalized for blindness, mutism (hospitalization duration: 10 day(s)). The events "loss of sight and inability to speak." required physician office visit and emergency room visit. Therapeutic measures were taken as a result of blindness, mutism.; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported events Blindness ,mutism and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug 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 Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202300252274 same patient and different drug dose/events.;US-PFIZER INC-202300252275 same patient and different drug dose/events.;
My nose is congested; Feels like the flu; My arm hurts; Headache; tired for 3 days; pain in my chest" 3 out of 10 intensity; Chest oppression/Like something was pushing my heart or lungs in the middle of my chest; This spontaneous case was reported by a patient and describes the occurrence of CHEST PAIN (pain in my chest" 3 out of 10 intensity), SENSE OF OPPRESSION (Chest oppression/Like something was pushing my heart or lungs in the middle of my chest), NASAL CONGESTION (My nose is congested), INFLUENZA (Feels like the flu) and MYALGIA (My arm hurts) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, the patient experienced CHEST PAIN (pain in my chest" 3 out of 10 intensity), SENSE OF OPPRESSION (Chest oppression/Like something was pushing my heart or lungs in the middle of my chest), MYALGIA (My arm hurts), HEADACHE (Headache) and FATIGUE (tired for 3 days). On 09-May-2021, the patient experienced NASAL CONGESTION (My nose is congested) and INFLUENZA (Feels like the flu). On 06-May-2021, CHEST PAIN (pain in my chest" 3 out of 10 intensity), MYALGIA (My arm hurts) and HEADACHE (Headache) had resolved. At the time of the report, SENSE OF OPPRESSION (Chest oppression/Like something was pushing my heart or lungs in the middle of my chest) and FATIGUE (tired for 3 days) had not resolved and NASAL CONGESTION (My nose is congested) and INFLUENZA (Feels like the flu) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       NO CONCOMTANT DRUG WERE USED Treatment Tylenol 500mg PO BID
Upset stomach in a shy very apprehensive girl. Offered juice but does not wish any. After waiting another 15 min only arm hurts, wants to go home with parents and they agreed to monitor and call 911 if new signs arise.
Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Additional Details: 2 minutes after the patient received her dose # 2 of Moderna vaccination she felt weak and needed to lay down in her car. She refused to lay down on the exam table. As she walked out of exam room she held on to mother and fell into mothers arms and was assisted to the floor by her mother. She had no loss of consciousness. She did not fall to the ground. Hypotension (81/52, HR 61, 98% 18) no difficulty breathing. Refused blood sugar check. Activated EMS but she refused to wait. Refused water.
My daughter received her vaccinations on 6/11/18. She was perfect until then but got a little sick a couple of days later and it went away. On 6/23/18 we had to call the ambulance because she was hot, in a daze like state and just wasn't acting herself. We were taken to the hospital then transferred to another hospital were images were done and they found bleeding on the brain and called an eye doctor in who found bleeding behind her eyes.
Initial report received from a healthcare professional on 18 April 2007.  A 23 year old, female patient developed a fever of 100 degrees and generalized achiness, after she received Adacel (lot number C2610AA, route and site of administration not known), Typhim VI (lot number Z0122-3, route and site of administration not known) and YF-VAX (lot number UE998AC, route and site of administration not known) on 15 April 2007.  She also received Gardasil (Merck, lot number unknown, route and site of administration not known) and hepatitis A vaccine (lot number unknown, tradename, route and site of administration not known) on the same day.  She was on antidepressants and did not have any illness at the time of the vaccinations.  It was not known if she recovered.  Follow-up information was received from a health professional on 14 May 2007 which provided the lot numbers for the Gardasil (01374) and hepatitis A (Merck, 00194) vaccines.  The lot number for Adacel was corrected to C2632AA (previously reported as C2610AA).  Additionally, it was reported that Adacel was given intramuscularly in the left upper deltoid, Typhim VI was given intramuscularly in the left lower deltoid, YF-VAX was given subcutaneously in the left arm, Gardasil was given intramuscularly in the right lower deltoid, and hepatitis A was given in the right upper deltoid.  The patient was seen at the college health service on 18 April 2007.  Recovery status remained unknown.  Follow-up information received on 04 June 2007 from a health care professional.  In response to a request for an update of the patient's recovery status, the reporter wrote that the patient was "seen at health services in a different location.  We have not heard back."  This case has the same reporter as case 2007-01314.
by 10-11 p.m. that night severe chills. did not sleep the entire night due to extreme headache, chills, fever (102+), body aches.  felt truly awful.     by 6 am Saturday feeling nauseated and wound up vomiting. Saturday night/Sunday -- not 100%, no appetite, intermittent nausea, but able to work/do normal activities. Monday 4/5--nausea at an 8-9 in the morning and kept a trash can next to me during virtual hearings I had that day.   Intermittent nausea throughout the week and not much appetite but made sure I was eating/drinking despite that.   Wednesday night 4/7 -- I went to use a PT stick on my left leg b/c I had felt a little pain in my left knee and figured my quadriceps were fibrotic.  I could barely put any pressure on my left thigh. I had never experienced anything like this.  As soon as I started rolling the stick on my leg, my skin was immediately red and warm and my leg was so sore and tender I had to stop.   Saturday 4/10 -- woke up with severe headache and later that morning felt very weird in my head/heart, like heart racing and my head felt "spinny."  Felt like I might pass out at one point so I had one of my kids sit on my bed with me until I felt a little better. Sunday 4/11 -- had another episode like Saturday (headache and lightheaded/spinny/pass out feeling/slow speech) and asked neighbor (an RN) to take my BP.  her at-home device said 147 over something and she suggested I go to urgent care just to double check.   About three hours later, I was seen at  urgent care.  BP was normal, heart rate normal, oxygen was 96.  4/13--followed up with primary doctor.  Send me for blood work to check platelets, etc.  Feeling pretty good today but nervous after the news and the pause.
Shortly after administration of the Gardasil 9 vaccine, patient experienced what seems to be a vasovagal episode and fell to the ground. He sustained a bloody nose as well as a laceration to his bottom lip as a result of the fall. On the floor, patient had his eyes open, but he did not speak and experienced tonic-clonic movements in his upper extremities, which lasted a few seconds (~5  sec) before recovery. The fall was witnessed by his father. Patient was visibly distraught after the incident with a bloody nose as well as a bloody mouth from his fall to the floor. Tissue was given to patient to help stop his bloody nose as well as water to drink. On exam, patient did have ~1 cm vertical laceration to his left inner lower lip, which stopped bleeding. He was able to drink water as well as suck on a popsicle. Patient remained coherent and remembered what he had for breakfast and lunch that day as well as his activities for later that day (a friend's birthday party at a bounce house). Patient was advised not to attend the party and to limit his activities for the next week and to follow up in 1-2 weeks in our office for reevaluation, sooner if things worsened.   Attempts made to contact the family on 1/18/20. Family contacted on 1/19/20 - Patient feeling better with a decrease in his lip swelling. He was still having some bloody noses, which stopped quickly with pressure. Appetite still slightly decreased. No reported difficulty with breathing. Advised family to have Patient avoid soccer activities for the next week until reevaluation.  Parents understood plan.
Janssen covid19 vaccine EUA.  Beginning 8 hours after shot, experienced severe chills, head ache, body ache, nauseas and fever which lasted about 18 hours.
2nd dose administered to patient from Expired vial; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2nd dose administered to patient from Expired vial) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 037A21B) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (2nd dose administered to patient from Expired vial). On 01-Sep-2021, EXPIRED PRODUCT ADMINISTERED (2nd dose administered to patient from Expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The concomitant medications were not reported. The treatment information was not provided  Nurse reported that one of her facilities gave 10 doses between 8AM - 12 PM on 01/Sep/2021 from a Moderna vial that expired on 31/Aug/2021..  It was a new vial that had never been opened. It had been moved into the refrigerator on 25/Aug/2021 (8 days prior).   Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: The follow up document was received and had  significant information. Added second dose details. Added race and ethnicity of patient  and vaccine facility information.
PATIENT HAD COME IN FOR THE SECOND DOSE OF THE SHINGRIX SERIES. PATIENT HAD ALREADY RECEIVED 2 DOSES LAST YEAR. PATIENT RECEIVED A THIRD DOSE TODAY. INFORMED PATIENT AND TO MONITOR FOR ANY SYMPTOMS OR DISCOMFORT.
1st Dose Moderna 1/9/2021 c/o arm and neck  stiffness with pain started within a few days of vaccine.2nd dose 2/6/2021 Moderna, had lip numbness, swelling w SOB x 4 days 45 minutes after vaccine administration.  Pre medicated with 25 mg Benadryl PO before vaccine was given.  3rd shot booster dose 11/1/2021 same symptoms as 2nd dose but lasted only 2 days and pre-medicated with 25 mg po Benadryl prior to vaccination.  2nd Booster dose 4/2/2022 pt pre-medicated with 50 mg Benadryl PO prior to vaccination.  She stated she had visited with her PCP Dr. and Dr. Infectious Disease to get a booster but not Moderna, She received a booster dose Pfizer, stayed 30 minutes in observation,  No issues stated or noted.
injection "was missed administered." / administered too high in the left arm and too close to the shoulder; decreased mobility of the  injected arm; small area turned "black and blue" / Black and blue area at injection site; excruciating pain; This case was reported by a consumer and described the occurrence of injected limb mobility decreased in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th December 2020, the patient received the 2nd dose of Shingrix. On 4th December 2020, unknown after receiving Shingrix, the patient experienced vaccine administered at inappropriate site. In December 2020, the patient experienced injected limb mobility decreased, injection site discoloration and pain. The patient was treated with cortisone (non-proprietary) (Cortisone Injection). On an unknown date, the outcome of the injected limb mobility decreased and pain were not recovered/not resolved and the outcome of the injection site discoloration and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the injected limb mobility decreased, injection site discoloration and pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient got her 2nd Shingrix vaccine and described as the injection was missed administered. The reporter stated that the vaccine was administered too high in the left arm and too close to the shoulder which led to vaccine administered at inappropriate site. The patient has had excruciating pain and decreased mobility of the  injected arm.  A small area turned black and blue. The patient reported she got an injection of Cortisone on On 8th December 2020. The patient stated that the Cortisone has helped but it still not fully recovered. The reporter consented to follow up.
One week after the vaccine,  (on  2/15/21) I began to have a headache and and back and joint pain.  I took ibuprofen for relief.  Later I noticed a 2" red, raised spot on the injection site.  The headache and body aches were gone by the next morning,  but the red rash was larger, the area felt warm, and it had started to itch.   I used a cortisone cream to relieve the itching.  Today (1/18/21) the red spot measures 4" x 3" and the area still is warm and continues to itch.  I'm continuing with the cortisone cream.  I contacted my primary care doctor and told her of my experience.
No adverse event, but error in administering vaccine after recommended 12 hours past 1st puncture of vial. Vial 1st punctured 7/13/21 at 11:50am and past expired dose used 7/14/21 at 6:48pm. Manufacturer provided guidance on reporting error to VAERs but did not recommend an additional dose at this time.
Roughly 1 minute after injections, mother noted possible syncopal event with recovery. Doctor (me) and tech evaluated and noted child to be slightly pale and sleepy though arousable. VS showed low normal BP and low normal heart rate. Child vomited once and continued to have varying levels of consciousness. Child and mother were escorted to the Emergency Room for evaluation. Child was evaluated and determined to have a vagal episode and discharged home.
information has been recieved from a registered nurse (RN) concerning a 70 yr old white female with penicillin allergy, arthritis, "aeroallergies", and bronchial asthma who on 04/15/2002 in the am, was vaccinated with a second dose of pneumococcal vaccine23 polyvalent (lot number 641114/1052L), administered SC, in the left arm. Concomitant therapy (dates not specified) included fluticasone propionate + salmeterol xinafoate (Advair Diskus) 250/50 "1x2", montelukast sodium (MSD) 10 mg HS, mometasone furoate (Nasonex cream) BID "to affected area". On 04/15/2002 about 30 mins after leaving the physician's office, the pt's left arm started to become painful and erythematous. She felt heat at the site and developed some swelling/edema. The discomfort and swelling continued and intensified overnight. The following morning, the pt went back to her physician and he gave her a diphenhydramine hydrochloride (Benadryl) injection, methylprednisolone acetate (Depo-Medrol) injection, and started her on a coarse of oral methylprednisolone (Medrol).At that time, the physician documented "?" reaction to pneumococcal vaccine 23 polyvalent. The pt reportedly had difficulty moving her arm. "Severe progressive local RX S/P pneumococcal vaccine 23 polyvalent) vaccine am 24 hrs was documented. The timing of the reaction was described as "nocturnal/exercise" and modifying factors included "exertion/weather". The pt also developed >150mm x 60mm induration of the left arm and general malaise. Associated signs and symptoms included nocturnal respiratory distress, chest tightness, and exertional dyspnea. She denied shortness of breath or dysphagia. Review of systems was completed, with the pt denying any additional complaints. Additional abnormal physical assessment findings included "moderate distress", nasal turbinates mildly edematous, and "SL PND" Lungs were reported to be "clear P & A" with "good breath sounds". Vital signs were as follows: pule 99, otic temperature 98.2, and BP 120/72, measured with a standard cuff. In additional, peak flow/vital capacity was reported as 285 and oxygen saturated was 96. It was documented that pulmonary function tests were last performed in April 2002, the pt recovered. the physician also reported that on an unspecified date in 1997 the pt was vaccinated with a dose of pneumococcal vaccine 23 polyvalent with no reactions or problems. Nocturnal respiratory distress, chest tightness, exertional dyspnea, "moderate distress", nasal turbinates mildly edematous, And "SL PND" were considered to be incidental findings. No additional information is available.
Suspected vaccination failure; got it over side face, in mouth jaw ear eye was really bad; shingles in ear; got it over side face/in mouth jaw was really bad; pain; he cryed; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant), herpes zoster oticus (serious criteria GSK medically significant), shingles, pain and crying. On an unknown date, the outcome of the vaccination failure, ophthalmic herpes zoster, herpes zoster oticus, shingles, pain and crying were unknown.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, herpes zoster oticus, shingles, pain and crying to be related to Shingles vaccine.  Additional details were provided as follows: The patient was reporter's father. The age at vaccination was not reported. The patient got shingles over side face, in mouth, jaw, ear and eye. The reporter stated it was really bad. The reporter had to take care of patient. The reporter stated it was awful see the patient, pain effected tongue and the patient cried. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, details regarding actual time to onset for target disease and laboratory confirmation were unknown at the time of reporting. No further information would be available.
1hr p/vax pt devel rt eyelid;this progressed to edema & erythema of both eyelids;
Pt recv vax on 10/12/98; on same day pt exp pain in LA; difficulty w/ pronation of left hand & picking up objects