chrisvoncsefalvay/vaers-outcomes huggingface dataset:
HEART PROBLEMS; This spontaneous report received from a consumer through a company representative concerned a 60 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient never had any heart problems before vaccination. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1), (suspension for injection, route of admin, batch number: Unknown and expiry date: Unknown) dose was not reported, 1 total administered, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the reporter stated that his girlfriend had heart problems and suddenly needed a triple bypass. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of heart problems was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20211245023 and 20211245900.; Sender's Comments: V0: 20211245964-COVID-19 VACCINE AD26.COV2.S-Heart problems. This event is considered unassessable. The event 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.
Extreme pain and swelling in the left leg surrounding site of DTAP vaccine with a limp.  Having trouble moving, walking and extreme tenderness in his thigh.
My 11 yr old son received the HPV injection and has a severe lump and pain in his arm from this medication.
Initial report received from the vaccine provider on 26/Jan/2006.  A 24-year-old female patient, with a history of an allergy to AUGMENTIN, received an intramuscular, right deltoid injection of DECAVAC, manufacturer sanofi pasteur, lot number U1637BA, on 19/Jan/2006.  The next day she experienced redness and pain at the injection site.  One day after that, she was examined in an emergency room and diagnosed with cellulitis and treated with intravenous ROCEPHIN.  She was also administered KEFLEX per os.  The patient had no illness at the time of vaccination, and other medications included ORTHO TRI-CYCLEN LO and LEXAPRO.  At the time of this report, the patient had recovered.
She had a severe allergic reaction; throat swelling; face tingling; face swelling; lips swelling; This non-serious case was reported by a consumer via sales rep and described the occurrence of allergic reaction in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included immunocompromised and shingles (had an outbreak of shingles at 19 years old).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced allergic reaction (Verbatim: She had a severe allergic reaction), throat swelling (Verbatim: throat swelling), tingling (Verbatim: face tingling), facial swelling (Verbatim: face swelling) and lip swelling (Verbatim: lips swelling). The outcome of the allergic reaction, throat swelling, tingling, facial swelling and lip swelling were not reported.   It was unknown if the reporter considered the allergic reaction, throat swelling, tingling, facial swelling and lip swelling to be related to Shingrix.     It was unknown if the company considered the allergic reaction, throat swelling, tingling, facial swelling and lip swelling to be related to Shingrix.   Additional Information: GSK Receipt date: 25-JUL-2023 The reporter reported that one of the staff members in his/her office where he/she had lunch received 1 dose of Shingrix at a local in late May early June 2023.  She had a severe allergic reaction as face, lips, throat swelling, face tingling. The pharmacist called and she went to the emergency room for treatment. The reporter did not consent to follow up.
@ home 1PM felt unwell while eating lunch;@ 1:30 began coughing, eyes red, eyelids darkened;2:30 p/resting 1/2hr, heart rate was 120;went to ER; adm for observation & test;neg findings (reported by husband);heart rate remained elevated;
Significant pain followed by swelling and redness around the injection site; systemic reaction with flu like symptoms- aches, weakness, and fever. Flu like symptoms have gotten better but the pain and swelling on the injection arm are still present. Tylenol was taken.
Generalized bright pink mottling of skin within 3-5 min of receiving PREVNAR #4 and VARICELLA #1. Mainly extremities. No edema. Pt given BENADRYL 1/2 tsp. PO with resolution of skin reactions within 15-20 min. No obvious distress to pt.
Patient was under the age of 18 at the time of vaccination. No other adverse results were reported by patient.
A report has been received from a Health Professional concerning a 7 year old, Male subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT started on 30-Dec-2013. The patient received an expired dose of FLUMIST QUADRIVALENT inadvertently on 30-Dec-2013. The outcome of the event of expired FLUMSIT QUADRIVALENT administered is unknown. The report was considered to be non-serious.
5 and half weeks pregnant.   Severe nausea, chills, stomach pain, extremely tired
Local reactions started 18 hrs after injection. Started with a rash, soreness, warm to touch and redness grew larger. She has mild pruritus. 7 1/2 cm x 11 cm area.
feeling horrible; Since the first dose he woke up with what mother states is herpes zoster on his lips; Arm hurt; headache; Tonsils hurt; didn't feel well; This is a spontaneous report from a contactable consumer (patient's mother). A 13-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, Lot number: EW0167, expiry date: Aug2021), dose 1 via an unspecified route of administration, administered in left arm on 13May2021 at 12:15, as 1st dose, single for COVID-19 immunization. The patient's medical history and other allergies compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity were none. The patient's concomitant medications were not reported. The patient had no family medical history relevant to AE. The patient received no other vaccinations within four weeks prior to the first administration date of the suspect vaccine. No additional vaccines administered on same date of the Pfizer Suspect. On 13Jan2021 at 20:00, 8 hours after getting the shot, the patient experienced tonsils started hurting. He didn't feel well and had headaches. On 14Jan2021, he had some pretty bad symptoms on Saturday morning, he woke up with herpes zoster on his lips and his mother called to pediatrician and he was very dismissive about it and said that if the body was under stress it can come out, but he never had anything like this before. It looks like little pustules around his mouth and looks like when my mom had shingles. He did mention his arm hurt a little but went to soccer practice. Clarifies the herpes zoster didn't show up until Saturday evening/night and it was starting to go away. She took son to get Covid PCR testing on 14Jan2021 and it was negative and was told that the herpes zoster was probably a reaction to the vaccine. The patient received treatment with Abreva. The outcome of the events Since the first dose he woke up with what mother states is herpes zoster on his lips was not recovered, and the other event feeling horrible was unknown, and all other events was recovering.   PSCC Communication: PC Filed Product Complaint: Yes, Description of Product Complaint: Description of complaint: Asks if this could be a bad one since he was so sick and took him to get Covid PCR testing and it was negative. Thought was weird since she and her husband both had the Pfizer Covid shot and did not have any reactions. This was son's first Covid vaccine, Lot number: EW0167, expiry.
Dizzy/Nauseous when moving eyes- especially when driving; Sweating profusely; Vertigo; High fever (103.3); Dizziness / Dizzy when moving eyes- especially when driving; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the right arm on 14Apr2021 at 18:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included psoriasis and vitiligo. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received promethazine (PHENERGAN) and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the right arm on an unknown date in Mar2021 at 15:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. On 14Apr2021, 5 to 10 minutes after the vaccination, the patient started sweating profusely and got vertigo which lasted for 3 minutes. On an unknown date in Apr2021, over the next two days, the patient experienced high fever of 103.3 (unspecified units) and dizziness. On 20Apr2021, 6 days after the vaccination, the patient experienced dizzy/nauseous when moving eyes, especially when driving. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sweating profusely and vertigo were resolved on 14Apr2021 while high fever (103.3), dizziness, dizzy/nauseous when moving eyes, especially when driving was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Swelling and redness on left arm. Pt had immunization on 7/30/13 (DTaP).
3 days sick; Threw up; Headache; 101.8 Fever; Ached all over; Very tired; This is a spontaneous report from a contactable consumer (reporting herself). This 74-Year-old Female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6198), via an unspecified route of administration in arm on 01Mar2021 at 14:50 as a single dose for COVID-19 immunization. Previously, the patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Ph9264), via an unspecified route of administration in arm on 09Feb2021 at 10:00 as a single dose for COVID-19 immunization. The patient's medical history reported as MONO-EBU started one year ago and its ongoing. The concomitant medication were not reported. On 01Mar2021, the patient experienced three days sickness, very tired, threw up, headache, 101.8 fever, ache all over in bed 3-day. The outcome of the event three days sickness was recovering, very tired was recovered and other events was unknown.
Had onset of intense headache and had difficulty breathing.  A nebulizer treatment was given and examined by a provider.  Her husband was summoned to bring her home to rest.
pt recv vax 7JUL97 & same day pt reported that arm was bright red & warm to touch from the site of inj to elbow in approx 9x8 inch area;pt devel swelling, which spread;p/48hr pt on med for poss cellulitis;WBC count 12,500;
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE HYPOTENSION ALLERGIC REACTION, SUBSEQ
Information has been received from a physician concerning a 15 month old patient who on 14-MAY-2008 was vaccinated with "one dose" of VARIVAX (Oka/Merck). On 17-MAY-2008 the patient couldn't walk. Patient went to a hospital on 17-MAY-2008 (unspecified if patient was admitted into hospital). As of 19-MAY-2008, patient was walking but with an abnormal wobble. Upon internal review, can not walk was considered to be disabling. Additional information has been requested.
last year she got the Pfizer injections (not verified if covid vaccines) and got the virus, Hospitalized in March for 5 days; last year she got the Pfizer injections (not verified if covid vaccines) and got the virus, Hospitalized in March for 5 days; last year she got the Pfizer injections (not verified if covid vaccines) and got the virus and now she has it again; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 92-year-old female patient received BNT162b2 (BNT162B2 NOS), in 2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant) all with onset 2022, outcome "unknown" and all described as "last year she got the Pfizer injections (not verified if covid vaccines) and got the virus, Hospitalized in March for 5 days"; DISEASE RECURRENCE (medically significant) with onset Feb2023, outcome "unknown", described as "last year she got the Pfizer injections (not verified if covid vaccines) and got the virus and now she has it again ". The patient was hospitalized for drug ineffective, covid-19 (start date: Mar2022, hospitalization duration: 5 day(s)). The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Feb2023) Positive, notes: got positive result on covid test. Therapeutic measures were taken as a result of drug ineffective, covid-19, disease recurrence (PAXLOVID). Last year the patient got the Pfizer injections (not verified if covid vaccines) and got the virus, Hospitalized in Mar for 5 days, and nowhas it again (pertaining to covid infection). on Sunday She had runny nose, sore throat and had trouble breathing, Yesterday went to medical places, got positive result on covid test.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
arm was sore; Arm was red; Arm had fever; Arm was raised and hard; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore), ERYTHEMA (Arm was red), FEELING HOT (Arm had fever) and INDURATION (Arm was raised and hard) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal and Bone disorder. Concomitant products included HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN/HYDROCHLOORTHIAZIDE), IRON and VITAMIN D NOS for an unknown indication.    On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jul-2021, the patient experienced PAIN IN EXTREMITY (arm was sore), ERYTHEMA (Arm was red), FEELING HOT (Arm had fever) and INDURATION (Arm was raised and hard). At the time of the report, PAIN IN EXTREMITY (arm was sore), ERYTHEMA (Arm was red), FEELING HOT (Arm had fever) and INDURATION (Arm was raised and hard) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was also given Pneumonia vaccine along with Moderna shot.   Treatment included application of rubbing alcohol on affected area.
Cough 8 days after the vaccine / Covid19 test / was negative; Soreness in / left leg / getting worse daily; Fatigue / Even going up the stairs exhausts him; "Pain in thigh and buttocks muscles"; decrease all of his daily activity; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Pfizer Covid19 Vaccine (received both doses of Pfizer Covid 19 vaccine on an unknown date), Pneumonia vaccine (received Pneumonia vaccine on an unknown date) and Zostavax (received Zostavax on an unknown date).   On 20th July 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 22nd July 2021, 2 days after receiving Shingrix, the patient experienced fatigue, muscle pain and activities of daily living impaired. On 28th July 2021, the patient experienced cough and leg pain. On an unknown date, the outcome of the fatigue, muscle pain, activities of daily living impaired, cough and leg pain were not recovered/not resolved.   It was unknown if the reporter considered the fatigue, muscle pain, activities of daily living impaired, cough and leg pain to be related to Shingrix.  Additional details were provide are as follows: The case was reported by patient himself. The patient stressed that he was very fit for his age and had an intense exercise routine he follows everyday. The patient had no adverse reactions from Zostavax, Pneumonia or Pfizer Covid 19 vaccines. The patient received 0.5 ml of 1st dose of Shingrix and 2 days after vaccination, patient began to had fatigue and pain in thigh and buttocks muscles and had to decrease all of his daily activity and even going up the stairs exhausted him and 8 days after vaccination, patient developed cough which was audible throughout the call and began to had soreness in his left leg was getting worse daily. The patient went to nurse about the cough, she said his lungs are clear and there was no fever and she would like him to see the doctor about the cough because she thought the cough was unrelated to the Shingrix vaccine. The patient had performed Covid 19 test which was negative. The reporter consented to follow-up.
27 year old female approached EMS crew complaining of slight headache. Denies SOB, nausea, pain, rash. Patient has no other complaint. Vital signs assessed and found to be within normal limits. Patient refused transport to hospital. Signed refusal with EMS.
Severe red swelling reaction in the left upper arm reported to me on 10/17/2018 at 2:15pm. Patient is seeing physician and applying cold packs to reduce the swelling.
This spontaneous report as received from an officer manager referring to a currently 1 year old female patient. No information was provided regarding the patient's medical history and concurrent conditions. The patient's concomitant medications included sterile diluent (MERCK STERILE DILUENT).  On 30-JAN-2018, the patient was vaccinated with an improperly stored dose of VARIVAX (dose and anatomical location and route of administration were not reported)  lot # M046004, expiration date: 18-NOV-2018 indicated for prophylaxis. The vaccine had not had any previous temperature excursions as recorded by a data logger. On an unknown date, VARIVAX had temperature excursions of   -14C to -10C  for a time frame of 7 minutes which was called by a data logger. There were no adverse effects reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1805USA000841: US-009507513-1805USA000923: US-009507513-1805USA000928: US-009507513-1805USA000925: US-009507513-1805USA000926: US-009507513-1805USA000927: US-009507513-1805USA000921: US-009507513-1805USA000924:
Patient reports feeling lightheaded, dizzy. Passed out a couple times. Presents sweating, flushing, and clammy skin. Patient reports having  veso vagal previously. EMs preformed EKG and results were normal. Refused EMS transport
I had body aches since the shot; I had diarrhea since the shot; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the right arm on 05May2021 at 14:30 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included symptomatic premature ventricular contractions (PVC's), pseudotumor cerebri, colitis, depression, anxiety, weak left ventricle and post-traumatic stress disorder (PTSD) and known allergies to sulfa, penicillin and plastic tape. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included rimegepant sulfate (NURTEC ODT) and clonazepam (KLONOPIN); both for unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the right arm on 14Apr2021 at 14:30 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. On 05May2021 at 15:45, the patient experienced body aches and diarrhea since the shot. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events body aches and diarrhea since the shot was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Right arm soreness high intensity for 10 days following vaccine. Pain started at left arm following right arm tenderness 06/07/02 pt states she is getting better. Doctor said this was not a result of inj. He diagnosed arthritis.
needle detached from the syringe (something faulty happened with the syringe); she is not confident the patient got the full dose; This spontaneous case was reported by an other health care professional and describes the occurrence of DEVICE CONNECTION ISSUE (needle detached from the syringe (something faulty happened with the syringe)) and UNDERDOSE (she is not confident the patient got the full dose) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced DEVICE CONNECTION ISSUE (needle detached from the syringe (something faulty happened with the syringe)) and UNDERDOSE (she is not confident the patient got the full dose). On 19-Apr-2021, DEVICE CONNECTION ISSUE (needle detached from the syringe (something faulty happened with the syringe)) and UNDERDOSE (she is not confident the patient got the full dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: NNI