chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning a 10-year-old female with no pertinent medical history or allergies who on 05-NOV-2007 was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck). There was no concomitant medication. On 07-NOV-2007, the patient developed a blister at the injection site; 15X14cm "erythematous"; "her arm was itchy", hurting and couldn't move; and a fever of 106 degrees after getting the second dose of varicella virus vaccine live (Oka/Merck). No diagnostic labs were performed. The patient sought unspecified medical attention. At the time of the report the patient's status was recovering. A product quality complaint was not involved. Additional information has been requested.
Narrative: Patient reported lightheadedness without other symptoms that resolved spontaneously. No intervention needed.
PATIENT GOT THE VACCINE AND WAS TOLD TO SIT DOWN FOR 15 MINUTES  . DURING THAT TIME PT FAINTED .CALLED 911 AND WAS TAKEN TO THE HOSPITAL
Though my period ended on March 6th, normally. My period started again on the 26th. It was accompanied by much more intense pain and cramping, as well as intense suicidal ideation. That period ended after a very heavy bleeding of 4 days. I got the second shot just before my 37th birthday and the very next day felt terrible. My entire body hurt in a way I have never experienced before. My feet hurt, my hips, extreme fatigue. That continues in varying severity. I started spotting again on April 19th, which continues until I started another period on April 23rd which just ended yesterday, the 26th. I am still very fatigued and have been dealing with extreme suicidal thoughts and uncontrollable crying.
BREAKTHROUGH INFECTION; CONFIRMED CLINICAL VACCINATION FAILURE; This spontaneous report was received from literature. This report concerned a patient of unspecified age and sex, race and ethnicity. The objective of this was to analysis the SARS-CoV-2 specific antibody and cellular responses in healthy vaccine recipients who experienced breakthrough infections a median of 50 days after receiving a booster mRNA vaccine. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no comorbidities. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series: 1) (suspension for injection, route of admin was not reported, batch number: Unknown and expiry: Unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. The patient received non-company suspect vaccine Elasomeran (Moderna) (Dose number in series: 2) (form of admin, route of admin were not reported, batch number: Unknown and expiry: Unknown), dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient had mild upper respiratory tract symptoms and experienced breakthrough infection (Dose number in series: 2) which was confirmed clinical vaccination failure (Dose number in series: 1). It was reported that, the days between booster shot and symptom onset was 34, days between symptom onset and blood drawn was 10, and days between booster shot and blood drawn was 44. Laboratory data (dates unspecified) included: Angiotensin converting enzyme (ACE inhibiting antibodies) (NR: not provided) slightly higher, and Antibody test (NR: not provided) Not reported. The action taken with covid-19 vaccine ad26.cov2.s, and Elasomeran (Moderna) was not applicable. The outcome of the confirmed clinical vaccination failure and breakthrough infection was not reported. The author emphasized that breakthrough infections with the Omicron variant can occur despite robust immune responses to the vaccine strain spike protein. This report was serious (Other Medically Important Condition). This case is associated with a product quality complaint, and reference number requested. This case, from the same reporter is linked to 20220430845 and 20220452187.; Sender's Comments: V0: 20220452198- covid-19 vaccine ad26.cov2.s - Breakthrough  infection. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable. 20220452198- covid-19 vaccine ad26.cov2.s- Confirmed clinical vaccination failure . The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
I had my vaccination on 05/15/2022. I started to feel unwell on 02/28/2023. I went to my primary doctor on 03/03/2023 with feelings of heart attack symptoms with left arm pain. I could not be upright without pain in my arm. I had an EKG on this date. I went to the emergency room on 03/05/2023 as my symptoms were much worse.  I was determined to have Shingles by default. I had a repeat EKG. I presently feel better on 05/15/2023.
Initial unsolicited case received from consumer via social media on 10-Oct-2016. This case is liked to 2016SA188144, 2016SA188556, 2016SA188803, 2016SA188804, 2016SA188805, 2016SA188806, 2016SA188807, 2016SA188808, 2016SA188809, 2016SA188810, 2016SA188811, 2016SA188812, 2016SA188813, 2016SA188814, 2016SA188815, 2016SA188816, 2016SA188817, 2016SA188818, 2016SA188819, 2016SA188820, 2016SA188821, 2016SA188822, 2016SA188833, 2016SA188834, 2016SA188835, 2016SA188836, 2016SA188837, 2016SA188838, 2016SA188839, 2016SA188840, 2016SA188841, 2016SA188842, 2016SA188843, 2016SA188844, 2016SA188846, 2016SA188847, 2016SA188848, 2016SA188849, 2016SA188850, 2016SA188851.. (same source, same vaccine). This case involves a patient (age and gender not reported) who was vaccinated with a first dose of flu shot (manufacturer: unknown, batch number, expiry date, route and site of administration: not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date, post vaccination, the patient was sick for a month and patient though that she would pass. Patient's lab data and corrective treatment was not reported. On an unspecified date, patient recovered from the event sick and outcome of the event though I would pass was not reported. List of documents held by sender: none.
Pt developed fever and had seizure several hours after having immunizations. Pt was taken to ER where he was given TYLENOL and Ibuprofen. No other treatment was required.
This spontaneous report as received from a licensed practical nurse (L.P.N) concerning to a 5 year old male patient with none drug reactions/allergies and none pertinent medical history. On 20-AUG-2013, the patient was vaccinated with VARIVAX (Merck) (dose, frequency, concentration and route of administration were not provided), lot number J002317, subcutaneous. There were no concomitant medications. On 20-AUG-2013, 12 hours later after vaccination; the patient experienced rash pruritic that appeared on the inner thigh and then spread from there to unspecified locations of the body. No laboratory studies were reported. On an unknown date the patient was given acetaminophen (manufacturer unknown) and hydrocortisone (manufacturer unknown ) as treatment for the event. No further information was available. At the time of this report the outcome of rash pruritic was unknown. The causality between the adverse event and the vaccine was unknown. Additional information has been requested.
Right lateral thigh 2x 4 cm of induration and 6x 8 cm of mild erythema , almost bruised looking. Prescribed Augmentin for treatment.
She got her vaccine, didn't have anything right away.  At 5:00 PM she was driving and suddenly feeling very off, got really light headed and her heart was racing, her chest was tightening and after a few minutes her fingertips went numb.  She also felt very weak in her legs.  She pulled over, called EMS and went to the ER by ambulance and everything there checked out normal.  She went to the ER.  She felt off for about a week and it happened again while she was driving without numbness in the fingertips the2nd time and went to another ER and they told her that everything they tested was normal.  Both the ER's told her to FU with a cardiologist ASAP and is waiting to get that appointment.    The 2nd hospital also did a chest x-ray and an EKG which was normal.  She did FU with her PCP last week and asked what happened and told her to see the cardiologist and again is still waiting for the PCP to contact her with that appointment.  The 2nd ER she went to.  Every once and a while she gets light headed, and she now has anxiety issues due to this condition and is anxious while driving for fear or this happening to her again, and also does not know what caused it but the only thing different is the vaccine.  She has gotten the flu shot several times in the past and has never had a reaction to it.    Last year in December she got the flu and the COVID vaccine in the same day but other than a lump under the armpit she did not have any other reaction, and the lump when away and could not physically see it.  She could not close the armput all the way due to the pain, but could not feel a lump.
pt recv vax 12MAY96 & 13MAY96 large amount of swelling, redness & tenderness of upper arm @ inj site
Patient experienced tiredness, fatigue, fever, chills, bone aches and cold symptoms again. this was 48 hours after the second dose. Patient experienced the same symptoms  from the first dose. They said its occurring every 3 months - symptoms were come up and then disappear and reappear again. they spoke to dr for the symptoms and dr didn't know what was going on.  this was just recently report 9/19/20 for both  shingrix vaccinations given in july 2019 and October 2019
Pt. in HD for Tdap. After administration Pt. had syncopal episode. Pt. did not hit floor but was assisted to floor by staff. Cold rag applied to forehead, Pt. fanned and feet elevated. Pt. immediately responded and answered questions appropriately. Sprite given to patient and Pt. remained in HD until she could walk without complaint. Mother present.
On March 19 at 2:36 PM. Post COVID-19 immunization observation, first dose for patient date of birth 915 1993. Instructions given for observation area for patient to notify immediately if any discomfort. Approximately 10 minutes post injection patient was noted to appear pale body extended in chair and arms and legs extended. Cell phone dropped to the floor, head extended backwards noted shifting of legs and arms. Direct attention given by myself Immediately. Patient alert, cold To touch and seemed to be slightly unaware for a moment but within seconds, patient stated she felt like she was dreaming and I woke her up. Was oriented to time and place and who I was as a person. BP 68 o2 83 pulse was weak and t
Client received vaccine at end of our clinic day around 4:05 pm. No history of severe allergies, only prior sensitivity to Avocado. During clients 15 minute wait she stepped outside complaining of being hot. A nurse provided water for client, as well as juice. She stated she felt better. Nurse accompanied her back in side, and went over other signs and symptoms of anaphylaxis. Client stated she was not experiencing any of those symptoms and that she felt better. When her wait was complete, she walked to the coat room with other employees, and her throat and ears  began to itch, and she was coughing to  help itch her throat. At this time the vaccine director was alerted and anaphylactic protocol was initiated. EMS was called- the time was 4:37 pm, pulse was 80, blood pressure was 178/108. 4:39- client refused epi, so 1mL/50Mg, IM Benadryl was given in the right deltoid. Simultaneously, a tourniquet was placed above the vaccine site on the left deltoid. Distal pulses monitored in left arm every 5 minutes. 4:41 itching and coughing increased, client agreed to Epi. 0.3 mg Epi pen given in right thigh. EMS arrive and transported client to hospital for observation.
Information has been received from a physician and the mother of a 27 month old female with no known medical history who on 08/27/2000 was vaccinated with a first dose of varicella vaccine SC in the left thigh. The pt was concomitantly vaccinated with a first dose of MMR vaccine SC in the right thigh and a first dose of Prevnar IM in the left thigh. There was no other concomitant medication and no illness at the time of vaccination. The pt's mother reported that the pt recently developed a fever for 12 days. The pt then developed chicken pox with about 40 lesions with none on the trunk. The pt's mother reported that 19 days from developing the rash, the pt had 6 open sores. The next day, the pt developed full blown chicken poxwith 100's of lesions spread over her entire body. Additional info received from the physician indicated that on 11/25/2001, the pt developed a generalized rash of varicella with 30 vesicles. On 11/27/2001, the pt was seen in the office and was diagnosed with a mild case of chicken pox. No diagnostic tests were performed. The pt's rash clinically appeared to be chicken pox. The pt had no fever or other systemic sign of illness. On 12/05/2001, the pt recovered. It was reported that the pt's mother (WAES0202USA00380) experienced secondary transmission after her daughter developed chicken pox post vaccination with varicella vaccine. No additional info is expected.
Right temple and eye were swollen and achy. Tear gland swelled outside of eye socket. Headaches. Gland is still swollen.
Upon entering information into system It was noted that the patient received her second booster earlier then schedule released by CDC.  Vaccine series is as follows: Pfizer 3/31/21, Pfizer 4/21/21, Pfizer 4/27/22  and Pfizer 7/27/22.   I attempted to contact patient at phone number listed on consent form to advise her of the information  and obtain additional information, but have been unable to speak with her as of yet.
This is a spontaneous report from a contactable consumer, the patient. A 69-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6198) via an unspecified route of administration in the left arm on 23Mar2021 at 08:30 (at the age of 69-year-old) as a single dose, for COVID-19 immunization. Medical history included high blood pressure and high cholesterol. The patient was allergic to penicillin. Concomitant medications were not reported. The patient had not received any other vaccine within 4 weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 24Mar2021 at 04:30, the patient experienced eyelids swollen, increasingly puffy, and itching. The patient was concerned about the impact on vision. It was unknown whether the patient received therapeutic measures for the events. The events had not resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events eyelids swollen, eyelids increasingly puffy, eyelids increasingly puffy were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Headache, Myalgia, Fever, UrticariaPruritus, Sire discomfort, redness, fatigue Narrative:
Feeling worn down; Fall asleep prior to meeting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, product=COVID 19, brand unknown=True, brand name unknown=COVID19 Vaccine), for Covid-19 Immunization. The following information was reported: FATIGUE (non-serious) with onset Sep2021, outcome "recovered" (2021), described as "Feeling worn down"; SOMNOLENCE (non-serious) with onset Sep2021, outcome "recovered" (2021), described as "Fall asleep prior to meeting".  Additional information: Clinical course: It was reported that fully vaccinated individual reported feeling worn down after attending football game and other event. Caused them to fall asleep prior to meeting. They were worried it was covid but I never got it confirmed from them whether or not it was. Patient submitted an AE for this before, but have not seen the follow up, and she was worried it didn't go through or forgot. Colleague said that they went to a college football game and then another event over weekend of 24Sep2021 and then were really worn down in the following couple of days. They accidentally fell asleep at one point. Patient unsure what vaccine they have, and believe they were tested for covid following this but patient unsure the results. Patient also not certain of other symptoms. Individual seems to have made a full recovery based on interactions with them. Patient awareness date is Monday 27Sep2021, but she was not sure if anyone else heard. Again, believe submitted for this before, but just did not hear a follow up.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fever (99-101 degrees)?administered Ibuprofen. Three-day duration. Fatigue. Three-day duration.
ACHINESS; HEADACHE; TIRED; INJECTION SITE RED; INJECTION SITE PAIN; INJECTION SITE WARM; This spontaneous report received from a patient concerned a 36 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 05-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-AUG-2021, the patient experienced injection site warm. On 05-AUG-2021, the patient experienced injection site red. On 05-AUG-2021, the patient experienced injection site pain. On 06-AUG-2021, the patient experienced achiness. On 06-AUG-2021, the patient experienced headache. On 06-AUG-2021, the patient experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from achiness, and headache on 11-AUG-2021, was recovering from tired, and had not recovered from injection site warm, injection site red, and injection site pain. This report was non-serious.
she accidentally administered an expired dose of ACT-HIB to one of their patients, with no reported adverse event; Initial information received on 24-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 1-year-old female patient who experienced she accidentally administered an expired dose of HIB (PRP/T) vaccine [ACT-HIB] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 11-Aug-2023, the patient received accidently an expired dose of 0.5 ml dose 4 of suspect standard strength HIB (PRP/T) vaccine powder and solvent for solution for injection (lot: UJ739ABA, Expiry date: 10-Aug-2023) via intramuscular route in unknown administration site for Immunisation with no reported adverse event (expired product administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown.   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 the guidelines. 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.
feels nauseous; has a headache; is fatigued; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (feels nauseous), HEADACHE (has a headache) and FATIGUE (is fatigued) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Seizures.    On 23-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Aug-2021, the patient experienced NAUSEA (feels nauseous), HEADACHE (has a headache) and FATIGUE (is fatigued). At the time of the report, NAUSEA (feels nauseous), HEADACHE (has a headache) and FATIGUE (is fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported by the reporter. No treatment was reported by the reporter.
Rash; Hives; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) and URTICARIA (Hives) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Family history included Primary biliary cirrhosis (mother had primary biliary cirrhosis).    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced RASH (Rash) and URTICARIA (Hives). On 09-Apr-2021, RASH (Rash) and URTICARIA (Hives) had resolved. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD21-083569 ; Sender's Comments:  MOD21-083569:
Mother states within 2 hours of vaccine, child had lethargy and mucous diarrhea that has been present intermittently since the 4th of August. He is hyper reactive to dairy now, where as he was not prior to vaccine. 2 days after when seen in  office child was still lethargic and staring off with minimal eye contact. He also would have mom hold him and whimper. This resolve about 2 days later when called to check on them.
Narrative:  COVID infections following completion of COVID vaccine series 03/02/21 COVID vaccine dose #1 03/23/21 COVID vaccine dose #2 07/27/21 Pt calls into CCC reporting blood in stool with colonoscopy scheduled for 08/04 08/01/21 Pt presents for preop COVID test with no symptoms - COVID POSITIVE 08/02/21 Pt remains asymptomatic 08/03/21 Pt reports he took a separate test and he was COVID negative
Fever, body aches, injection site redness, cellulitis down the arm to the elbow.
Moderna COVID-19 Vaccine  First injection: 01/22/2021 ( left Deltoid ) ; Second injection: 02/19/2021  ( right Deltoid ) Pain remaining in both injection sites continuously after injections beginning three days after innoculation. More pronounced in right arm and extends to antecubital fossa area. Pressing on injection sites causes increased pain. No improvement since innoculations.
Itchy rash at the injection site, warm and firm to the touch, about the size of a baseball
The patient developed tingling sensation of her arms and is having numbness. She felt that she can not move, 5 minutes after receiving the Flu shot. Code blue was initiated. She is given Epipen , within 5 minutes after she developed the symptoms. Her vital signs are being monitored. She is given Oxygen via rebreather, because her Oxygen saturations are relatively low. her hands are relatively cold to touch during the event. She is stable, except that initially she is feeling that she can not move and with numbness of the extremities. She was transported via ambulance to the local ER of the hospital.
Extremely painful sores/ulcers/swelling on vulva.  Extremely difficult to sit, walk, and urinate. As of today (Tues Dec 14), no improvement. Nurse practitioner at school ruled out other causes & prescribed topical ointment & anti-viral medication. Advil & Tylenol for pain.