chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient developed a grand mal seizure, new onset, the day after the HPV vaccine, dose #2. Did well with first dose. 8/19/08-records received for DOS 7/20/08-DC DX: Generalized tonic clonic seizure. Presented to ED with first time seizure. Had not eaten anything that day. Drank  ETOH night before. Sleeping poorly due to stress.
Case number PHEH2014US021297 is an initial spontaneous report received from a pharmacist on 20 Oct 2014 with a follow-up received from a pharmacist on 25 Nov 2014. This report refers to  20 years old female patient. Her medical history and concomitant medications were not reported. Concomitant vaccinations included FLUVIRIN (batch number: unknown) and Hep-B (batch number: AHBVC199AA, other manufacturer). She was vaccinated with an expired dose of MENVEO (batch number A13011, expiry date: Not reported) at a dose of 0.5 ml, intramuscularly on 19 Oct 2014 at 03:00 PM in error. No adverse events were reported following the inadvertent administration. Follow-up received from a pharmacist on 25 Nov 2014: Dosage of MENVEO (0.5 ml), time of vaccination (03:00 PM), and concomitant vaccinations (FLUVIRIN and Hepa-B) were updated.
arm swollen at injection site; at the injection site, reallysore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (arm swollen at injection site) and VACCINATION SITE PAIN (at the injection site, reallysore) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 047B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced VACCINATION SITE SWELLING (arm swollen at injection site) and VACCINATION SITE PAIN (at the injection site, reallysore). On 28-Mar-2021, VACCINATION SITE SWELLING (arm swollen at injection site) and VACCINATION SITE PAIN (at the injection site, reallysore) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment of events was not reported. Concomitant medication use was not provided by the reporter.
The pt experienced mild erythema, swelling of left deltoid area, and left pectoral. Pt was treated with Prednisone and Depo Medrol.
fever; chills; This spontaneous case was reported by a physician and describes the occurrence of PYREXIA (fever) and CHILLS (chills) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced PYREXIA (fever) and CHILLS (chills). On 05-Feb-2021, PYREXIA (fever) and CHILLS (chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Feb-2021, Body temperature: inconclusive (Inconclusive) Inconclusive. On an unknown date, Antibody test: negative (Negative) Negative a month later of vaccination..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications provided.  No treatment drugs were reported.  Action taken with mRNA-1273 in response to the events was not Applicable.
Arm was very sore to the point that she can't raise arm. Can't move without excruciating pain. It's not swollen, but hurts to the touch.
pfizer-biontech covid-19 vaccine eua. got my period 2 days after first vaccine which i received on 04.14.21. period was 2.5 weeks early and lasted for two weeks.  got period again 5 days after second dose which i received on 05.05.21. has lasted on and off so far for a week. longer period, cramping. terrible mood swings.
Information has been received from a company representative concerning 3-5 children (males and females) who in 9/00, were vaccinated with MMRII (lot 636658/1141K). Seven days, post vax, the pts experienced rash and/or fever to 102F. There was a concern because all of the pts received vaccine from the same lot. The records of testing prior to release of this lot have been checked by Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. In follow-up, the physician reported she "did not have those records any longer and the reactions are as detailed as she knew." The physician reported that she was just reporting "an increased frequency of issues with one lot of vaccines, last year and did not have more details." No further information is available.
Date and time adverse event started:  ringing of the ears 3-28-21, 4-5-21 numbness face  4/8-recommended he get seen by his pcp or local ER to r/o bells palsy or stroke like symptoms related to his reported numbness to unilateral side of his face. caller verbalized understanding. caller spoke with no slurr and was oriented X4 during the call
Tired; Waves feeling sick to her stomach; Lots of pain; Lots of pain including fingers; This case was reported by a consumer via sales rep and described the occurrence of pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included paracetamol (Tylenol) unknown for pain and pain in fingers.   On 22nd July 2022, the patient received the 1st dose of Shingrix. In July 2022, the patient started Tylenol at an unknown dose and frequency. On 23rd July 2022, 1 days after receiving Shingrix, the patient experienced pain and pain in fingers. On 25th July 2022, the patient experienced tiredness and upset stomach. The action taken with Tylenol was unknown. On an unknown date, the outcome of the pain, pain in fingers, tiredness and upset stomach were unknown.   It was unknown if the reporter considered the pain, pain in fingers, tiredness and upset stomach to be related to Shingrix.     Additional Information: GSK Receipt Date: 25-JUL-2022 Reporter's Comments: The patient was in lots of pain including fingers.   3 days after receiving Shingrix, the patient was tired and in waves feeling sick to her stomach.
patient received 2 doses of Typhim VI dose 7.5 weeks earlier; Initial information received on 25-Apr-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 47 years old female patient who experienced patient received vaccine TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI].  The patient's past vaccination(s) included Hepatitis A, Hepatitis B and MMR receiving vaccines over the last month. The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant medications included RABIES VACCINE (RABIES VACCINE) for Immunisation three doses in series on date 22-Mar-2019, 29-Mar-2019 and 12-Apr-2019.  On 01-Mar-2019, the patient received a dose first dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE (Solution for injection) lot number not reported via unknown route in unknown administration site.   On 24-Apr-2019, the patient received a second 0.5 mL dose of the same vaccine TYPHOID VI POLYSACCHARIDE VACCINE (Solution for injection) lot PZA881M, expiry date- 22-SEP-2020 via unknown route in the left deltoid.  It was a case of actual medication error due to Inappropriate schedule of vaccine administered.  The patient received a prior Typhim VI dose 7.5 weeks earlier. Occupation Health Nurse reports a female worker who will be traveling received a second Typhim VI dose on 24APR2019 due to missing paperwork in her chart documenting that she had already received the vaccine on 01MAR2019.  It was unknown if any adverse event was occurred.   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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.  Documents held by sender: none.
Information ahs been received form an RN concerning a 65 year old female pt who on 30SEP2003 was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine. On 13OCT2003, the pt developed a rash on her neck and arms. Unspecified medial attention was sought, but the pt was not hospitalized. The pt treated her rash with calamine lotion. A product quality complaint was not involved. Additional information has been requested.
hot to the touch; Body aches; injection area it is read; injection area it is Swollen; fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (hot to the touch), PAIN (Body aches), INJECTION SITE ERYTHEMA (injection area it is read), INJECTION SITE SWELLING (injection area it is Swollen) and PYREXIA (fever) in a patient of an unknown age and gender 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 FEELING HOT (hot to the touch), PAIN (Body aches), INJECTION SITE ERYTHEMA (injection area it is read), INJECTION SITE SWELLING (injection area it is Swollen) and PYREXIA (fever). At the time of the report, FEELING HOT (hot to the touch), PAIN (Body aches), INJECTION SITE ERYTHEMA (injection area it is read), INJECTION SITE SWELLING (injection area it is Swollen) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided.
After about 5 minutes, patient had difficulty breathing and appeared to be close to syncope. Breathing was observed to be shallow, infrequent, and labored. Called emergency services and administered one dose of epi-pen to the patient.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in right arm for COVID-19 immunisation; BNT162b2 (BNT162B2), in Jun2021 as dose 1, single (Batch/Lot number: unknown), in left arm, in Dec2021 as dose 2, single (Batch/Lot number: unknown), in right arm and in Jun2022 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for COVID-19 immunisation. The patient's relevant medical history included: "Diabetes mellitus" (unspecified if ongoing); "Allergy to bell peppers" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, COVID-19 which included PAXLOVID from 22Dec2022 to 26Dec2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received 2nd dose of vaccine and patient reports that the injection was painful to the arm. She then states that later that afternoon around 12:30 she started to experience pain in her left leg and then proceeded to all over muscle aches. Patient was in bed for two days with pain continued for a week. Now resolved. Required heating pad and OTC tylenol.
She got 1st booster dose on 3/23/22. She came in today (4/8/22) to report.  She said 1 day after she got Moderna booster dose,  her arm was swollen, redness, and tender when touch and the swollen was get bigger almost down to her elbow. This last for about a week.
Hips and legs felt like they were on fire, burning; Terrible pain and agony; Feel weak; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the left arm on 16Apr2021 at 13:30 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included avascular necrosis in both hips and both legs around the knees, caused from factor five and chronic pain. The patient had known allergies to bupropion hydrochloride (WELLBUTRIN). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included unspecified drugs that were prescribed and over-the counter. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 26Mar2021 at 13:30 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Apr2021 at 18:30, the second evening after the second dose, the patient experienced hips and legs felt like they were on fire, burning, terrible pain and agony just for few hours. The patient stated that the pain slipped on after taking a nap in the early evening and the patient woke up to the terrible pain, was able to settle down and relax, and the pain was just gone. The patient still felt weak, but no more burning pain. The events did not result in doctor or other healthcare professional /clinic visit, emergency room/department or urgent care. 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 hips and legs felt like they were on fire, burning, terrible pain and agony just for few hours and feeling weak was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
One half hour post vax, the pt experienced swelling around the eyes. This became progressively worse. The child was taken to an urgent care facility. The face was very swollen, red, and a rash had begun to develop on legs, arms, abdomen and back. The pt was given Adrenalin, Benadryl and Valium. Swelling began resolving within 1/2 hour.
Tested positive for Covid 19; Tested positive for Covid 19; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 22Oct2021 (Lot number: FF2590) at the age of 50 years as dose 3 (booster), single, administration date 01Mar2021 (Lot number: EL3247) as dose 2, single and administration date 08Feb2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset 22Oct2021, outcome "unknown", described as "Booster"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 27Dec2021, outcome "recovered" and all described as "Tested positive for Covid 19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (28Dec2021) positive, notes: covid test type post vaccination: Other,. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Clinical Course: The patient had no known allergies.The patient had no other vaccination in the past 4 weeks. The patient did not have Covid prior to vaccination and tested positive to Covid after vaccination.  No follow-up attempts are possible. No further information is expected.
experiencing lightheadedness/dizziness; sick; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 79 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 26Feb2021 (Lot number: EN6200) at the age of 79 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "experiencing lightheadedness/dizziness"; ILLNESS (non-serious), outcome "unknown", described as "sick".  No follow-up attempts are possible. No further information is expected.
2 hours after receiving vaccine client c/o itching, swelling, redness around site.  Had extreme sweeling from shoulder to elbow.  Saw PCP who ordered "antibiotic" and ice to area.  48 hours after vaccine still had some redness and swelling but much improved.
Infection in my submandidular gland. Face is swollen and in a lot of pain.
severe surface full body pain to the touch; It seemed as if my musclesweren't sore but everything on top of them was; skin was painful; so much severe pain unable to do anything for the remainder of the day; severe headache/head pain; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 04May2021 at 14:30 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was allergic to azithromycin (MANUFACTURER UNKNOWN).  The patient did not receive any other medications within two weeks of the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 13Apr2021 at 14:30 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 05May2021 at 03:30, the patient experienced severe surface full body pain to the touch, it was seemed as muscles were not sore but everything on top of them was sore. The skin was painful to touch and the patient was in so much severe pain and unable to do anything for the remainder of the day. This also came along with a severe headache/head pain that has lingered since. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events severe surface full-body pain to the touch, muscles were not sore but everything on top of them was sore, skin painful, so much severe pain and unable to do anything for the remainder of the day, and severe headache/head pain were recovering at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Shingles dx 02/09/2005, s/p varivax 06/04/2002
The DOB in the appointment registration did not match the DOB in the Immunization Information when the dose was uploaded revealing that the client was under the currently authorized age at administration. The parent was notified and acknowledged that the DOB was entered incorrectly in the appointment registry so the client was given Pfizer at age 15 when it was only authorized down to 16.
Systemic: Fainting / Unresponsive-Medium, Additional Details: Pateint fainted within 5 minutes of receiving the vaccine.  911 was called and responded but he had quickly come to.  He felt better within 10 minutes but the paramedics examined him anyway.  He left of his own accord.
resembled a panic or heart attack but not as severe; panic attack; Sweating; Increased heart rate; Pounding heart, racing heart; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 18-year-old male patient received bnt162b2 (PFIZER COVID-19 VACCINE), administered in arm left, administration date 10Jan2022 (Lot number: FL3209) at the age of 18 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 1), for COVID-19 Immunization, reaction: "Had no side effects at all"; Covid-19 vaccine (Dose 2), for COVID-19 Immunization, reaction: "Had no side effects at all". The following information was reported: MYOCARDIAL INFARCTION (medically significant) with onset 13Jan2022, outcome "recovering", described as "resembled a panic or heart attack but not as severe"; PANIC ATTACK (non-serious) with onset 13Jan2022, outcome "recovering", described as "panic attack"; HYPERHIDROSIS (non-serious) with onset 13Jan2022, outcome "recovering", described as "Sweating"; HEART RATE INCREASED (non-serious) with onset 13Jan2022, outcome "recovering", described as "Increased heart rate"; PALPITATIONS (non-serious) with onset 13Jan2022, outcome "recovering", described as "Pounding heart, racing heart". The patient underwent the following laboratory tests and procedures: heart rate: (13Jan2022) increased. Clinical course: The university the patient went to said needed it unless he wanted to do mandatory testing. Patient received his third dose of bnt162b2 (clarified with caller that it was a booster dose) on 10Jan2022. Randomly today (13Jan2022) when he was sitting on the couch watching videos, he developed an extreme panicky feeling that overtook him. It almost resembled a panic or heart attack but not as severe. There was no pain but patient had sweating, increased heart rate, pounding heart, racing heart and feeling panicked all together. There was nothing that was scaring patient or that could increase his heart rate and it came of no where. It was more of a panic attack. Denied any chest pain. Denied any hx of prior panic attacks. Patient had the vaccine a couple of days ago. Patient didn't know if symptoms could still be there for this long after. Patient didn't know if this is from the vaccine or not but it started after he received that third dose. The first two doses that patient had before the third dose, he had no side effects at all. This panicking feeling was on and off and it came back. When the panic attack came it was lessened and not as bad as the first time it happened on 13Jan2022. It started 30 minutes after he ate lunch around 13:30 on 13Jan2022. Provided qualifying statement that this was in no way a diagnosis (ie myocarditis).  No follow-up attempts are possible. No further information is expected.
Severe Headache for 24 hours Flu-like symptoms for 24 hours Achy Joints for 24 hours Mild fever for 24 hours Sore arm with reddened skin around injection site Took 1 Tylenol 3 times in 24 hours
Pt stated she had swelling, redness, and itching at injection site for the last 2-3 days. She put ice on the area and hydrocortisone cream. Pt is going to f/u w/her primary care physician.