chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Idiopathic Partial Facial Paralysis / Bell?s Palsy. Symptoms began six days after second dose of Moderna vaccination. Write facial paralysis with some numbness and weakness. Right vision was blurry. After examination, bloodwork, magnetic resonance imaging, was treated with corticosteroids (prednisone, 50 mg per day) for 14 days, Pantozol 20mg/day and Calcimagon 1 tablet/day, as well as prophylactic Valtrex 2x500mg/day for 5 days. Symptoms eventually resolved and recovered after 14 days of therapy
Patient received 1st dose of COVID vaccination on 2/17/2021 (lot: 031M20A exp 3/11/2021). Wife called today (2/19/2021) to report patient has been experiencing adverse drug reactions: tired, lack of appetite, temperature of 102.9 (eve of 2/18/2021) and 102.4 (am of 2/19/2021), vomiting (phlegm). Patient said he was feeling better this morning and is managing the temperature with acetaminophen. Of historical note, patient did test positive for COVID virus a few months ago. I instructed wife to continue monitoring side effects and encouraged use of acetaminophen to help with fever. I educated that the side effects are "expected" with the exception of vomiting. I also informed her that I would be filing a report with VAERS to report the adverse reaction. At this time, I do not believe these side effects exclude him from receiving the second dose, and I encourage him to still receive the 2nd dose when due (3/17/2021).
pain started in 1996, diagnosed with ankylosing spondylitis in 2007
I had the first vaccine shot in early April but it's been 4 months.; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (I had the first vaccine shot in early April but it's been 4 months.) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (I had the first vaccine shot in early April but it's been 4 months.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (I had the first vaccine shot in early April but it's been 4 months.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No Treatment medications were reported.
Pt woke up from nap at 3PM same day and started screaming (non stop) x 30 mins and was given Tylenol with stopping of crying but began to sleep and difficult to wake up and refused to feed for next 12 hrs. Pt finally started to drink Pedialyte next morning.
I had to rest for a day, soreness in arm, just normal reactions; she's had all Moderna vaccine starting with first dose received 3 yrs ago, and with the first one, the reactions were strong; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (I had to rest for a day, soreness in arm, just normal reactions) and IMMUNISATION REACTION (she's had all Moderna vaccine starting with first dose received 3 yrs ago, and with the first one, the reactions were strong) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 15-Jun-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (I had to rest for a day, soreness in arm, just normal reactions) and IMMUNISATION REACTION (she's had all Moderna vaccine starting with first dose received 3 yrs ago, and with the first one, the reactions were strong). At the time of the report, PAIN IN EXTREMITY (I had to rest for a day, soreness in arm, just normal reactions) and IMMUNISATION REACTION (she's had all Moderna vaccine starting with first dose received 3 yrs ago, and with the first one, the reactions were strong) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. Suspect product dosage text was reported as unknown. It was reported that patient mentioned that because she had strong reactions to vaccines, she goes with milder vaccines. She explained that mild one work just as good. Reporter stated that she's had all Moderna vaccine starting with first dose received 3 yrs ago, and with the first one, the reactions were strong, her reactions were milder with the boosters. Some examples reported were, she had to rest for a day, soreness in arm, just normal reactions.  No treatment information was provided.   This case was linked to MOD-2023-749699 (Patient Link).   Reporter did not allow further contact
Subject in pneumococcal vaccine trial, with severe COPD, was hospitalized on 3/26/2009 with vertigo and small bowel obstruction. Vaccination took place on 6/13/2007. According to the physician the relationship is 'None'. We would be happy to forward the Study's SAE reporting form upon request.  6/19/09 Received SAE for hospitalization of 03/26-3/27/2009. FINAL DX: vertigo, diverticulitis, partial small bowel obstruction Records reveal patient experienced diarrhea, vomiting & vertigo.  ICD9 Codes: 386.9, 560.
got Covid; got Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown), in Apr2021 as dose 2, single (Batch/Lot number: unknown), in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) and in May2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation.  The patient's relevant medical history included: "tobacco user" (unspecified if ongoing), notes: He is considered for life insurance as tobacco user. The patient took concomitant medications. He takes a lot of vitamins (unspecified). The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "got Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: On 3rd day he tested positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Additional information: Patient got vaccine probably in Apr2021 got 1st dose and 3weeks later 2nd. Then it was all over the news get booster. He got in Nov2021 but not same day. Then got another the next May2022 which was 6 months. Then Nov2022 got next booster. He started Paxlovid with unknown start date. He doesn't go to doctor until at deaths door. On 3rd day he tested positive and had telehealth and they sent order to (name-withheld).   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Patient was accidently given 5 extra doses of the Pfizer Covid Vaccine. Patient was given 1.8 ml of the vaccine instead of 0.3 ml. Patient was monitored by both a Physician Assistant and a Medical Doctor. 911 was called. Patient denied any symptoms and refused to go with the ambulance to the hospital for close observation. Patient signed out AMA. Patient advised by provider to seek medical attention if she developed fever, chills, vomiting, or any severe side effect from the vaccine.
had fever of up 102 for 12 days following DTP/HIB; had convuls 24FEB92;
Information has been received on 31-JUL-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. In 2016, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. Later in 2016, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster or shingles.  As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
He received the vaccine around 4:00 pm two days ago, once he woke up symptoms of redness and swelling had continued but welting had expanded around the site of injection. Mother gave him Benadryl at night, child states it did not help, but mother states it put him to sleep. This morning is was a bit larger, area in the center has remained constant. Surrounding erythema, up to about 2 hours ago, was more of a white color. Measures 4cm x 3cm.
2:15-2:30 Varicella inj. given. 3:00-3:15 To doctor office, throat swollen, hives all over, face swollen, Given Epinephrine 0.15 ml- Subq. Benadryl 200 mg-IM. 3:30 Hives gone.
This spontaneous report was received from a registered nurse refers to an unspecified number of patients of unknown age and gender. Pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown dates, patients were vaccinated with an improperly stored dose of GARDASIL, lot # L007828, expiry date 02-MAR-2017; lot # K010574, expiry date 08-APR-2017, (dose, frequency and route of administration not reported). No adverse effect reported. The outcome of events was unknown. No product quality complaint (PQC) was involved. No further details provided. This is one of five reports received from the same reporter. Additional information has been requested.
On 7/13/2004 around 1600 had 4 months shot given: Pediarix , HIB + Prevnar. Immediately started screaming inconsolably. Lasted 30 minutes in clinic, slept for 1 hours, woke up crying, 1 hour and half to 10:30 PM. Woke up around 7am crying again. Refused breakfast and cups of juice in cup.
Started breaking out in hives 2 days after injection. I had same reaction w/ 1st injection. Saw allergist, dermatologist- biopsied one of the spots. Dermatitis, non- specific.
The patient developed a rash on her face and other areas approx 3 days after shot. She took BENADRYL per her doctors instructions, but the rash continued until 11/3-11/4. She saw her doctor at this time and they referred her to allergist.
sweating; limited mobility in left shoulder; left arm pain, warmth and fatigue; left arm pain, warmth and fatigue; left arm pain, warmth and fatigue; chills; This spontaneous report has been received from a pharmacist, referring to a 77-year-old male patient. The patient's concurrent conditions included hypertension, esophagitis and hyperlipidemia. The patient had no drug reaction or allergy. The patient's concomitant medication included vitamin D.   On 13-MAY-2013, the patient was vaccinated with the first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot# S018405 with expiration date 28-MAR-2021; strength, dose, frequency were not reported) intramuscularly in the left deltoid for prophylaxis.  On 31-DEC-2019, the patient developed chills, sweating, limited mobility in left shoulder, left arm pain, warmth and fatigue. The patient had sought for medical attention. On 02-JAN-2020, the patient was admitted. On the same day, the patient had a left shoulder arthroscopic irrigation and debridement. On unknown dates, the patient had following tests (result not provided): complete blood count (CBC); C-reactive protein (CRP); comprehensive metabolic panel (CMP); basic metabolic panel (BMP); blood culture and culture of fluid from shoulder. At the time of the report, the patient was still in the hospital receiving intravenous vancomycin. The outcome of events was reported as recovering. The causality assessment was not provided by the reporter. The pharmacist was requesting a lot check for this lot of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23).   Upon internal review, all the events (required left shoulder arthroscopic irrigation and debridement) were considered to be medically significant.
Patient has chickenpox despite 2 doses of Varivax 2/6/08.
A non serious spontaneous report of administration of expired FLUMIST has been received from a health professional concerning a 6-year-old male patient. The patient's medical history and concomitant medication details were not provided. The product expired on 12-Dec-2010. The patient received the expired FLUMIST on 14-Dec-2010. On 21-Dec-2010, the patient was administered another dose of FLUMIST as the previous administered dose was expired. 05-Jan-2011, the reporting nurse reported that the patient did not experience any adverse events after receiving either of the FLUMIST doses. Since there was no adverse event associated with this vaccination error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. Additional information was received on 05-Jan-2011 and incorporated into the narrative.
tested positive for Covid 19/states that her and her mom tested positive for Covid 19 on Saturday, but their symptoms started Friday night; tested positive for Covid 19/states that her and her mom tested positive for Covid 19 on Saturday, but their symptoms started Friday night; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 40 years for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure high" (ongoing), notes: has had for years, may have been 36 or 37 when she was diagnosed; "Obesity" (ongoing), notes: started when she stopped using drugs, that was 6 years ago. There were no concomitant medications. The patient did not receive any other vaccinations within four weeks prior to the last administration date of the Pfizer Covid 19 vaccine. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 16Dec2022, outcome "recovering" and all described as "tested positive for Covid 19/states that her and her mom tested positive for Covid 19 on Saturday, but their symptoms started Friday night". The patient stated that her and her mom tested positive for Covid 19 on Saturday (17Dec2022), but their symptoms started Friday night (16Dec2022). Her brother also has Covid 19. Patient stated that they got it while working at the nursing home. Patient stated that they were feeling a lot better.  She had also been having diarrhea, but she did not know if it's from the PAXLOVID or Covid 19. The patient underwent the following laboratory tests and procedures: Covid 19 test: (17Dec2022) Positive. Therapeutic measures were taken as a result of 'drug ineffective, covid-19' which included PAXLOVID (Batch/lot number: GF3597, Expiry Date: Apr2023) which the patient started on 17Dec2022 at 300mg and 100mg, 3 tablets twice daily. The patient stated that her fever had been gone for 24 hours, and she was going to her job on 22Dec2022 to retest to see if she is still positive.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Armpit of injected arm swollen and sore; Armpit of injected arm swollen and sore; This is a spontaneous report from a contactable healthcare professional, the patient. A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot ek5730) solution for injection in the left arm on 19Dec2020 at 14:00 (at the age of 29-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included fibromyalgia, depression, anxiety and ADHD (attention deficit hyperactivity disorder). Concomitant medications were unknown. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 20Dec2020, the patient experienced armpit of injected arm swollen and sore. No treatment was provided for the event armpit of injected arm swollen and sore. The outcome of the event armpit of injected arm swollen and sore was recovering. Since the vaccination, the patient has not been tested for COVID-19.
This case was reported by a nurse and described the occurrence of weight loss in a 22 year old female pt who was vaccinated with hep B vaccine (Engerix B) for prophylaxis. The pt had no known drug allergies and no adverse experience following immunizations. There were no concurrent medications. The pt had been immunized against hep B as a child. Her employer required her to receive a second series of hep B vaccine although no titers had been measured. The reason for the second series of vaccine was unknown. On 6/6/03, the pt received the 5th dose of Engerix B, the second dose in the second immunization series. On 6/7/03, one day post-immunization, the pt began to experience headache, malaise, and shaking chills. Later in the day, she developed a fever as high as 102 degrees F, a rash on her chest and upper extremities, nausea, arthralgia, and myalgia. By 6/11/03, she had lost six pounds and was admitted to the hospital. The events persisted as of 6/13/03. The immunization series was discontinued. Comment: The reporter stated that the pt received Engerix B from 537A4; however, this is not a valid lot number.  Follow up on 07/11/2003: "Additional information was received from the treating infectious disease specialist on 07/09/2003.  The physician wrote, "it was initially thought that this patient had a reaction to Engerix B vaccine.  All serologies were negative and the symptoms were considered related to the vaccine.  Recently she was discharged from the hospital and was doing well and improving.  A several (sic) days later her husband came down with the same symptoms and rash and therefore her symptoms should not be from the Hepatitis B vaccine."  Comment: The reported stated that the patient received Engerix B from Lot # 537A4; however, this is not a valid lot number."
Fever,chills, body aches, headache, heart flutters(skips a beat), sob.
felt delirious; felt lightheaded; had a terrible dream; felt nauseous; A spontaneous report was received from a consumer reporting on himself, an 88-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and felt delirious/MedDRA PT: delirious, felt nauseous/MedDRA PT: nausea, felt lightheaded/MedDRA PT: lightheadedness, and had a terrible dream/MedDRA PT: terrifying dreams.   The patient's medical history was not provided. Concomitant medication use was not provided.   On 11 Feb 2021, the patient received their second of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection. The patient reported that during the night, he felt lightheaded, had a terrible dream, felt nauseous and delirious. The patient felt better the following day and his primary care physician was aware of the side effects. Treatment for the events included paracetamol.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events of felt delirious, felt nauseous, felt lightheaded and had a terrible dream were considered recovering/resolving.; Reporter's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested. Company assessed the event to be unlikely related to company product.
Starting 12 hours after the injection she had a fever of 101.5 degrees F lasting over 20 hours. She also experienced severe body aches, flank pain, bilateral groin and axillary nodal pain.
Flu type: including chills, fatigue, headache, body aches lasting for 24 hours.
Fever of > 104 degrees developed evening of 04/22/02. Immunizations given between 10 and 11 am that morning. Fever lasted 24 hours.
Breakthrough case admission after 4 vaccines Moderna 3/30/21 Lot# 030A21A;  Moderna 4/26/21 Lot# 007B21A;  Moderna 11/12/21 Lot# 034F21A;  MOderna 4/26/22 Lot# 065K21A
Tested positive for COVID after getting both vaccines; Tested positive for COVID after getting both vaccines; This is a spontaneous report from a non-contactable consumer. A 23-years-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection), dose 1 via an unspecified route of administration on 28Jan2021 (Batch/Lot Number: EN5318; Expiration Date: 31May2021) as DOSE 1, SINGLE for covid-19 immunization and BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection), dose 2 via an unspecified route of administration on 17Feb2021 (Batch/Lot Number: EN5318; Expiration Date: 31May2021) as DOSE 2, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced tested positive for Covid after getting both vaccines on 14Jun2021. The patient underwent lab tests and procedures which included sars-cov-2 test on 14Jun2021 and found positive. It was reported that the patient's SARS-CoV2 antibodies at diagnosis were unknown. Patient was not patient hospitalized or admitted to an intensive care unit. Patient's clinical signs at rest indicative of severe systemic illness were unknown. The Patient did not require supplemental oxygen (including high flow or ECMO) or receive mechanical ventilation. Patient did not experience any new or worsened symptoms/signs or multiorgan failure during the COVID-19 illness experienced. The Patient did not require any additional therapies or initiation of new medication or other treatment or procedure for COVID-19. The patient did not provide any medical history or chronic illness. Patient's smoking habits or routinely medication was unknown. The patient's pre-existing diseases worsened during the SARS-CoV2 infection or patient been treated with immunomodulating or immunosuppressing medications or received any other vaccines around the time of COVID-19 vaccination were not provided. The sample of the product available to be returned, if requested and Packaging sealed, and intact information was not provided. The outcome of events was recovering.  Follow-up attempts are needed. Further information been requested
Arthus reaction in right arm started approximately 4 hours after injection. Swelling increased for 24 hours.
fever, sweats, achy all over, arm pain both arms, leg pain both legs. lower back pain, headaches, light headiness, cough
intense erythema & pain lt shoulder, site of inject & circum 3x2 cm; itchy generalized rash noted 12 hrs p/still there 1 wk later;
p/vax pt exp painful; swollen rt arm from shoulder to elbow which was warm to touch;as of 6/3/99 condition as ongoing
Extreme itching; hives; dermatographia and feeling of a bubble in the throat.