chrisvoncsefalvay/vaers-outcomes huggingface dataset:
6x4 cm erythema, induration Left thigh at site of DTaP injection 08/03/05. Tender small pustral at injection site. parent and child on liberal warm packs and started on Augmentin at 42mg/kg 2D with follow up in 48 hours.
This spontaneous report was received from a nurse practitioner regarding 3 or 4 adult patients in the 30's. The patients had a medical history of shingles. On an unknown date the nurse practitioner vaccinated "3 or 4 adult patients" who were younger than 50 years of age with ZOSTAVAX. She reports that ZOSTAVAX was administered at the patient's requests because they had a history of shingles and they wanted to receive ZOSTAVAX to prevent further outbreaks. No symptoms were reported. Additional information has been requested.
Patient being observed post covid vaccination for hx of anaphylaxis with nuts and many foods.  At 30 minute mark, he was observed to have faint hives at left side of face and under chin.  Trunk clear.  No s/sx of distress.  Evaluated by EMS - mouth, throat, lungs clear to auscultation .  Patient and his mom decline Benadryl IM - discharged to home.  Intends to take PO Benadryl.
Patient developed chest pain  on 5/9 and had an EKG read as Normal sinus rhythm  Deep S in V2, consider posterior hypertrophy, Nonspecific T wave abnormality.  on 5/10 developed a low grade fever of 100.4 and patchy vesicular rash on the left arm that is neither painful or itchy.  Complaining of "pins and needles" feeling on arm and  tense bicep mucsle.
Patient became nauseous in the morning 2 days after getting both vaccines (had never had a problem with Pfizer vaccine).  In the morning she even lost consciousness though she did not say or know for how long.  Also became hot and started sweating a lot.  Patient did not tell me treatments she used but she is fine now.
Patient and father came in for her administration of her COVID vaccine. Patient was very nervous about the vaccine. After administration the patient passed out  and eyes rolled back and looked as though she was going to start seizing. I asked the patients father about calling 9-1-1 and he said no. Patient came to, but was very scared.  I offered to take her blood pressure her blood pressure and brought her water. As soon as I pressed the button the patient had another episode. The father and I agreed that we would call 9-1-1.  I proceded to call. During this time the father indicated that she has had an episode like this recently. So it appears that it is not related to the vaccine administration.  We sat them in the back office  on the couch until the fire department and paramedics came.
Pt recvd vax on 8APR91 & on 30APR91 devel Haemophilus influenza, type B bacteremia & was hospitalized; On 11SEp91 & 9FEB92 pt recvd 2nd & 3rd dose of vax; addtl info has been requested;
This spontaneous report as received from a healthcare professional refers to an unspecified number of patients. In approximately 2015 (reported as since 13-MAR-2015), the patients were vaccinated with doses of oral, ROTATEQ lot # K010221, K011663, K016313 and lot # reported as K015816 (expiration dates, dose, route and site of administrations were not reported) that were exposed to temperatures outside of the recommended range. No adverse effects had been observed or reported. Follow up information has been received from the medical assistant on 02-JUL-2015 regarding the patient of an unknown age and gender who on 02-JUN-2015 was vaccinated with a dose of oral, ROTATEQ (lot number K016313) (dose and route were not provided). There was 87 hours excursion. This lot number was received on 08-APR-2015. This is one of several reprots from the same reporter. Additional information is not expected as all correspondence was received.
This spontaneous case reported by a patient, describes the occurrence of exposure via breast milk (breastfeeding mother received mRNA-1273, Moderna COVID-19 vaccine, during pregnancy) in a 43-year-old female's baby exposed to mRNA-1273 (Moderna COVID-19) for immunization. No medical history reported. On Jun 19, 2021, patient received the 1st dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. Last menstrual period and estimated date of delivery: not provided. On an unknown date, her baby exposed via breast milk (breastfeeding mother received mRNA-1273, Moderna COVID-19 vaccine, during pregnancy). At the time of the report, exposure via breast milk (breastfeeding mother received mRNA-1273, Moderna COVID-19 vaccine, during pregnancy): outcome unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information provided. This case linked to MOD-2021-254173 (parent-child link). See case MOD-2021-254173 for details regarding the parent case.
p/vax sx described as label-behavior change, diff breath, hoarseness, rash, weakness, low energy, fast heart beat;
Pt has a hx of premature atrial contractions and paroxysmal, supraventricular tachycardia which is controlled with a beta blocker medication. Shortly after receiving his fourth Anthrax vax, he developed palpitations which lasted 12 hours.
Fever, chills, headache, joint pain, muscle pain, pain at injection site  Fever lasted 2 days all other symptoms except pain at injection site lasted 3 days. Injection site pain is on going
severe gout lasting 45 days, colcicine and alpurinol ineffective at controlling pain and swelling.  severe blistering on back of calves, itchy and blistering flesh
On February 4th after my first dose I had a sore arm, I walked down the hall and felt dizzy and a start of a headache. Went to grab water to take an Aleve/Tylenol and I passed out. Went to urgent care that day around 10:00AM and they said that everything looked fine and there was nothing they can do. After 24 hours I didn't feel dizzy and was back to my normal daily activities.
Flu like symptoms, extreme fatigue, & nausea, diarrhea, chills, fever, hallucinations and confusion
Blister at site of administration; This case was reported by a nurse via sales rep and described the occurrence of injection site blisters in a female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced injection site blisters. On an unknown date, the outcome of the injection site blisters was unknown.   It was unknown if the reporter considered the injection site blisters to be related to Bexsero.  Additional details were reported as follows: The age at vaccination was not reported. The nurse informed that a patient experienced blister at site of administration. The reporter did not consent to follow up.
The individual received 2 doses of PNEUMOVAX, 2.5 weeks apart in error - 8/20/2018 and 9/5/2018. Both vaccines were same lot number. The individual stated after 1st immunization, mild sore arm. After second immunization, he states that he had a "severe" sore arm, swelling, redness, headache, and body aches for 24/36hrs; resolved at 48hrs when notified patient of error.
Red circle at injection site the size of a tennis ball, lasted for 2 weeks. Became covid positive after 1 week.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Jan2023 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 34 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Bicuspid aortic valve" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: patient took Paxlovid for treatment of COVID-19 from 03Jun2023 to 07Jun2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300225098 Same reporter/patient, different drug/event.;
received GARDASIL 9 and got HPV from the vaccine; This spontaneous report as received from a physician assistant via a company representative, refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant drugs were not reported.       On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis.        On an unknown date, she experienced Human papilloma viral infection (HPV). It was unknown if the patient received any treatment or if any lab diagnostics or studies were performed. The outcome of the event was unknown.   The reporter considered the event to be related to hpv rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (reported as got HPV from the vaccine).
fever; body aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and MYALGIA (body aches) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever) and MYALGIA (body aches). At the time of the report, PYREXIA (fever) and MYALGIA (body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-317635, MOD-2021-317617 (Patient Link).
Very sore arm, many aches , muscle in legs seemed to be fatigued, lymph nodes in neck very swollen felt like a not or small ball in throat when swollowing.  Is this normal and if I get next shot will it be worse.
dizziness -Pt came into the clinic for her 2nd HPV vaccine. -5 to 10 mins after shot Pt felt dizzy while in waiting room
After receiving second dose of COVID-19 vaccine, developed 100.5 temp, shakes, and feeling unwell.  Unable to work scheduled shift.
flu like symptoms for 3 days - achey body, headache, diarrhea, nausea, fatigue
Racing heart. Sharp, stabbing pains in abdomen, breast, neck. Nausea. After 30/40 after inj. Took 75 mg Diphenhydramine . Racing hearbeat diminished after 15 min. Tenderness and pain in multiple sites continued and got worse in 1st 24 hours. Leveled out and continued for another 24. On a count of 0-10 pain was a level ten.
Soreness down the arm when administer, toes tingled,  later that day sore all over , felt very tired and felt like sleeping.  Still feeling sore all over after a few days.
Patient said they did not have any Multiple Sclerosis flair ups until they had their covid vaccine. Patient said they were fine after their first shot, but they took their second Moderna vaccine on 2/27 and two days later they felt numb all down their right side. They also stated their brain and their walking weren't synced. The patient went to the ER thinking it was a stroke, but they had an MRI done to confirm they relapsed. The MRI showed a white mass on their brain. The patient said they still have MS symptoms, but they come and go.
got vaccine completed 1/5/2021, waiting 20 minutes to check for reaction. Drove back to work. By the time i got back to work I had a  very itchy rash from just above injection site on my left arm down to my belly. This rash finally went aware mid day on 1/6/2021 and i also had Nausea from the night of 1/5/2021 to 1/9/2021. I contact my Employee Health Department when i returned to work 1/7/2021.
Child vaccinated at school clinic. Mother gave vaccinating nurse child's shot record. Child vaccinated according to shot record and requirements for entering kindergarten. School nurse called later in day to notify PH that she had a more up to date shot record on child than what mother had and that child only really needed to have 2nd varicella vaccine. No adverse events noted.
This spontaneous report as received from a female patient of unknown age, with no reaction/allergies and no pertinent medical history, concerning herself. On 26-APR-2012 the patient was vaccinated with a dose of ZOSTAVAX 0.65 ml, subcutaneously (lot number not reported). No other co-suspects were reported. Concomitant medications included: unspecified thyroid medication, vitamins (unspecified) and unspecified hormone pills. The reporter stated that she had a rash after getting the ZOSTAVAX which lasted a few weeks. The patient reported that on 28-APR-2012 ("by the following Saturday") she developed a slight temperature. On 15-MAY-2012 her arms were "itchy like crazy" first on the left forearm and then the right forearm. The patient developed lesions that when scratched burst and had clear liquid come out of them. Her rash then spread toward upper arms, legs, chest and back, and appeared at different places and different times with a burning itching sensation. Unspecified antihistamine was took to counteract the rash symptoms. It has been reported that the rash has gone away at that point. The patient was recovered from the events. No laboratory diagnostic studies were performed. The patient did not seek medical attention. Additional information is not expected.
(all dates are 2021)He had his first COVID vaccine on Feb 2nd - then he went to Punta Cana on Feb 3rd. He got a lot of sun while there, and when he returned had extensive light spots on his skin. He has a photo on his phone dated Feb 6th that showing no hypopigmentation the central chest or abdomen and only faint hypopigmentation at the flanks. He was evaluated in clinic on Feb 18th and noted to have hypopigmented annular patches extensive on the trunk and upper thighs.  He was treated with ketoconazole shampoo and cream and ciclopirox cream. His 2nd COVID vaccine was March 2nd.   From his Feb 18th visit to the April 15th visit, the hypopigmented areas on the trunk became depigmented and hypopigmentation spread to arms and legs.  His skin lesions did not respond to treatment prescribed on Feb 19th.  Biopsy done on April 15, 2021 was consistent with inflammatory vitiligo.  Unknown if coincidental that vitiligo developed at that time, but temporal correlation and fast progression is suspicious for vaccine relation.
Pt presented to Medical Center 10/28/09 with gen weakness and cough. Progressively worsened thru day, resulting in upper extremity paralysis. Treating physician mayor dx Guillain-Barre with secondary dx pneumonia. Pt in ICU when vaccine administrator notified 10/29/09 at 5 pm. Follow-up call today patient now on ventilator. Please contact infection control preventionis for more information on the hospital course. 11/5/09:  ED Record and Hospital Records received for dates of service 10/28/09 to 11/3/09. Final Dx:  Acute Infectious Polyneuritis, Pneumonia (organism NOS), Acute Respiratory Failure, Hyposmolality, Debility NOS, Hypertension NOS, Hyperlipidemia NEC/NOS, Cardiac Dysrhythmias NEC.   Assessment:  Presented to the ED with 2 wk. hx. of flu like sx. of congestion and fever and a cough that causes chest pain as well as generalized weakness to the entire body with trouble walking and grasping.  Tachycardic and hypoxic.  Rales and rhonchi in L base.  IV antibiotics and supplemental oxygen given. Intubated and managed in the ICU. IVIG initiated. Open tracheostomy tube placement.  Discharged after 6 days. 11/5/09:  ICD 9 Codes received:  357.0, 486, 518.81, 276.1, 799.3, 401.9, 272.4, 311, 960.4, 967.1, 389.3, 033.1.  12/1, 12/4, 12/3 Medical records and discharge summary received for:  DOS 10/28-11/03. Final DX:  Guillan-Barre syndrome, respiratory failure s/to Guillin-Barre, pneumonia, sinus tachycardia, hypophosphatemia, HTN, hyperlipidemia  History as above.  Apparently patient was candidate for outpatient therapy but upon discharge was unable to get out of wheelchair and was held for admission. Transferred from med-surg floor after ascending paralysis.  Transfer to ICU.  Intubated for resp distress. Tracheostomy. IVIG x5 days w/no improvement. Transferred to another hosp for plasmapharesis.   DOS 11/03-11/20. Final DX:  respiratory failure requiring mechanical ventilation, status post tracheostomy, new percutaneous endoscopic gastrostomy tube for feeding, bilateral infiltrates, sepsis status post treatment, presumed GBS leading to quadriplegia, altered mental status, generalized myopathy.   No improvement w/plasmaphaeresis, Transferred to another facility for supportive care.  Quadriplegia.  Able only to move eyebrows.  Completely flaccid upon exam.  Facial droop.  Bil ronchi.  Transient malignant HTN BP 208/107, stabilized. Atypical rapidly progressing GBS.
body aches; headache; mild discomfort; This is a spontaneous report from a contactable physician (patient) via a Pfizer sponsored program Pfizer First Connect and Medical information team. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received her vaccine 02Jan2021 and was experiencing body aches and headache in Jan2021. The patient asked if she can  take Tylenol, ibuprofen or Excedrin or some version of a pain reliever. The patient was having mild discomfort in Jan2021. The outcome of the events was unknown.  Information about Lot/Batch number has been requested.
SEIZURE LIKE ACTIVITY; SYNCOPE; CHEST PAIN; HYPOTENSION; DIZZINESS/LIGHTHEADEDNESS; VOMITING; PALLOR; DIAPHORESIS; TACHYCARDIA; ANXIETY-RELATED EVENTS; NAUSEA; This spontaneous report was received from multiple patients. No past medical history or concurrent conditions were reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported,1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patients experienced seizure like activity, syncope, chest pain, hypotension, dizziness/lightheadedness, vomiting, pallor, diaphoresis, tachycardia, anxiety-related events, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the anxiety-related events, syncope, chest pain, hypotension, dizziness/lightheadedness, nausea, vomiting, pallor, diaphoresis and tachycardia was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210553168-covid-19 vaccine ad26.cov2.s-syncope and seizure like activity. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
He gets confused; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old male patient received bnt162b2 (BNT162B2), administration date 31Mar2021 (Lot number: ER8732) at the age of 64 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "disability" (unspecified if ongoing), notes: He has been on disability for 8 or 9 years., Caller clarified that he was disabled and had diabetes prior to receiving the vaccine.; "Diabetic" (unspecified if ongoing), notes: He is a diabetic., Caller clarified that he was disabled and had diabetes prior to receiving the vaccine. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (first dose , Lot number: it is either ENB206 or EN0206.), administration date: 10Mar2021, when the patient was 64 years old, for COVID-19 Immunization. The following information was reported: CONFUSIONAL STATE (non-serious) with onset 2021, outcome "unknown", described as "He gets confused".  Additional Information: He was calling to check. He did his vaccine. He was not sure if he was calling the right place. He gets confused. When can he get the other one. They said he could make another appointment. He got the first one on 10Mar2021 and the second one on 31Mar2021. Now, he had got to get another one. Reporter states he doesn't have a side effect or product complaint. He called up because they said he could do it already. He was on disability. He has a lot of problems. He was a diabetic. He has been on disability for 8 or 9 years. Reporter clarified that he was disabled and had diabetes prior to receiving the vaccine.   No follow-up attempts are possible. No further information is expected.
After vaccine, pt had mental confusion, felt unsafe to drive, had difficulty speaking x 6 hours. Leg weakness x 4 hours.
The arm pain hasn?t gone away, still there worse and worse everyday. I have to  take Advil everyday, that only relieves  the pain partially. If i don?t take it I can?t  stand the pain. It?s been more than 2 months. Don?t think this is normal
12.22.20 @ 20:30 injection site pain, radiating pain to right elbow and neck, tingling in right 4th, & 5th finger 12.23.20 @ 05:45 awoke with headache, body aches and continued pain in right arm 12.23.20 @12:45 headache worsened, continued arm pain, fatigue 12.23.20 @ 14:30 elevated temperature 100.2 and chest palpitations and nausea 12.24.20 @ 10:53 "killer headache, and body aches.  No fever since yesterday night w/o taking reducer fever medications." BP1 164/106 Individual took her BP again in the other arm: BP2 162/109 She stated she will take Tylenol, and rest for 30 minutes to take her BP again. She stated she will contact her PCP after this. 12.24.20 @ 12:03 BP 129/90 Individual stated she contacted her PCP and PCP is aware of this event.
Expired vaccine is stored and then administered; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Expired vaccine is stored and then administered) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vaccine is stored and then administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Expired vaccine is stored and then administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  The vaccine was placed in refrigerator on 29-Oct-2021. The vaccine did not go any temperature excursion and patient did not experience adverse event.  No treatment information was provided.
Patient vaccinated with TDAP 9-2-10. 9-7-10 - c/o "weakness and leg pain". 9-15-10 - Patient seen in ED (weakness/shaking/back pain) - discharged same day.