chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sick; This case was reported by a consumer and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional details provided were as follows: The case was reported by patient for himself/herself. Age at vaccination was not reported. The patient received the shot of Shingles vaccine and it made him/her sick. Follow-up would not be possible as no contact detail available.
Had a low-grade fever (99.6 to 100.2), chills, and body aches.  These lasted less than 24 hours.  I took ibuprofen.
This case was reported by a healthcare professional and described the occurrence of syncope in a 18-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline), MMR II (Merck). Concurrent medical conditions included fainting. Concurrent medications included Triamcinolone and FLONASE. On 7 September 2011 at 11:15 the subject received 1st dose of TWINRIX at 0.5 ml in the left arm while in a seated position. On 7 September 2011 the subject also received 1st dose of MMR II (Merck). On 7 September 2011, immediately after vaccination with TWINRIX the subject experienced syncope and fell. She had also been injected with MMR II (Merck) and experienced a seizure immediately following. Fainting was also reported. The healthcare professional considered the events were disabling, life threatening and clinically significant (or requiring intervention). The subject was taken to the emergency room where she was discharged the same day. A systemic shot reaction was reported. The subject was told by cardiology that she had experienced a vasovagal response. Syncope, seizure, fainting and falling were all reported to have resolved. Attribution of these events to vaccination with TWINRIX was not reported.
Patient woke up Sunday morning with congestion and unable to speak clearly and had a low grade fever. He woke up Monday morning with a temp of 100 and still congested. Went all day Monday with a temperature of 100. Monday night around 5:00 patient became tired. Checked his temp again and it was 103. Within an hour it shot up to 105 and he's throwing up. I'm planning to take him in to see his pediatrician in the morning unless an emergency takes place and I need to get him seen sooner.
20 y/o male w/ papular rash located to arms bilaterally belt line with feet. Symptoms started 5 days ago, described  as pruritic, non tender. No associated fever or chills. Only 1 small pustular lesion noted on (R) arm.
Pt said hurt at injection site and it hurt her joint. We think she meant bone. She went to MD and MD said could not do anything. We called pt today 9/13/13 and she's feeling better now.
Swelling at injection site for several days, pain in arm of injection for over a month, bruise that lasted more than a week, a red spot still remains where the injection was given and is still painful to touch. She is following up with her physician next month (February) at her already scheduled annual appointment to discuss red injection site and pain.
pt recvd vax & 10 hrs p/vax pt had flu-like sx that lasted 3 days; sx subsided;
Respiratory distress increasing over next several minutes after vaccines. Per MD orderss - Epinphrine 1mg given SQ and 25mg Benadryl given IM. 911 called and oxygen via mask placed at 6L min. EMS takes over at this point. Patient to ER.
Rash in the back and buttock area/ patient was treated with Decadron 8 mg Intramuscularly
Temp of 104.7F, mom states that she called doctor and was told to give Tylenol and bath. Temp went down but later came back up to 103F. Later when child was at doctor's office, he told mom that it might have been the vaccine but she didn't have record with her for him to look at.
More than 42 days elapsed from first vaccine dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 42 days elapsed from first vaccine dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 42 days elapsed from first vaccine dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 42 days elapsed from first vaccine dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medication was not provided.  The treatment information was not provided.  The reporter mentioned that he was fine after the fist dose. As he was going to leave town he was unable to take the second dose of Moderna vaccine. There was an elapse in receiving the second dose that is more than 42 days from the first dose.
Fever; chills; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 02Oct2023 at 14:45 as dose 4 (booster), single (Lot number: HF9275) at the age of 51 years, in right arm for COVID-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation, on 14Sep2023 as dose number unknown, single; TDAP taken for immunisation, on 14Sep2023 as dose number unknown, single. Vaccination history included: Covid-19 vaccine (Dose number: 01, Manufacturer: Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose number: 02, Manufacturer: Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose number: 03, Manufacturer: Unknown), for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 03Oct2023 at 06:30, outcome "recovering", described as "Fever"; CHILLS (non-serious) with onset 03Oct2023 at 06:30, outcome "recovering". Therapeutic measures were not taken as a result of pyrexia, chills.  No follow-up attempts are possible. No further information is expected.
Patient felt dizzy immediately after the vaccination  and had near syncope, used alcohol the near before Sa2 97 HR 127 BP 144/96  Repeat after fluid and juice 10:20 am - 98% HR 97 BP 152/102 He felt better and requesting to go home left after 45 mins OBS
Received their booster of the Moderna COVID-19 vaccine 3 months after their second dose instead of 6 months; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received their booster of the Moderna COVID-19 vaccine 3 months after their second dose instead of 6 months) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078J21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Dec-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received their booster of the Moderna COVID-19 vaccine 3 months after their second dose instead of 6 months). On 22-Dec-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received their booster of the Moderna COVID-19 vaccine 3 months after their second dose instead of 6 months) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment medications reported.
Bright red itchy and painful rash on left arm at injection site. Size 7" Length, 4" Width
patient reports less than 48 hours after vaccination a swollen lump and rash on left scalp area at hairline. The area did not itch or was painful. The actual arm that the vaccine was given in was left deltoid sc. That area was also red and swollen mildly.
Pts husband reported that pt had numbness and tingling in arm and nausea/vomiting followed by inability to walk. Taken to ER work up under way for differential diagnosis including vaccine adverse event.
Chills, nausea 8-27-10 T 99 degrees 8-30-10 left earache, headache T. 97 degrees.
10 minutes after the injection I felt my blood pressure rise up.  When I got home it was 134/94, machine told me I had mild hypertension. When I measured a few hours later it was at 137/90. It remained like that until the evening when it lowered back down to 120/87. Later that evening, I had a fever and took Tylenol to help. My headache got worse in the evening as well. Arm was sore. This morning (day after my 1st dose) my BP was at 108/79, fever creeped up as the day went on, body aches, arm was hurting more,  headache continued, pressure on chest made it a bit hard to breathe, dizziness, some nausea, brain fog.
Headache, Myalgia, NauseaVomiting, FATIGUE Narrative:   Other Relevant History:
Inadvertently administered 0.2 ml of adult formulation of Pfizer/BioNTech, rather than pediatric formulation of Pfizer/BioNTech. Discovered within five minutes of injection, while documenting lot number in record. Monitored x30 minutes. Informed mother, immediately after discovery of incident. No adverse effects during the 30 minute monitoring period
Swelling of lips & tongue given BENADRYL, methylprednisone and epi. SQ.
Site: Pain at Injection Site-Mild, Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Hypertension-Mild, Additional Details: pt got vaccine  at 1115a. complained of fast HR and dizzziness. Was given benadryl. pt vitals were stable upon discharge
Got pneumonia; Date of vaccination 2016/2017; This spontaneous report as received from a currently 77-year-old male patient, referring to himself. The patient's medical history, previous drug reactions or allergies and concomitant medications were not reported.    On an unspecified date in 2016, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) (reported as "pneumonia")' on an unknown date in 2017, pt received another dose of pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) for prophylaxis (strengths, doses, routes of administration, anatomical locations, lots numbers, and expirations dates were not reported) (inappropriate schedule of product administration).          On an unknown date, the patient experienced pneumonia .    The outcome of pneumonia, and the causality assessment between pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) and the aforementioned event were not reported.  Upon internal review, pneumonia was determined to be a medically significant event.  This is one of two reports received from the same patient.; Sender's Comments:  US-009507513-2003USA009026:
audio and visual hallucinations; diarrhea; low blood pressure; earache; mental fog; coordination problems; head rushes; crackling; Eyes not following finger test; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATIONS, MIXED (audio and visual hallucinations) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included SIMETICONE (GAS X), PARACETAMOL (TYLENOL) and VITAMINS NOS for an unknown indication.   On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced HALLUCINATIONS, MIXED (audio and visual hallucinations) (seriousness criterion medically significant), DIARRHOEA (diarrhea), HYPOTENSION (low blood pressure), EAR PAIN (earache), FEELING ABNORMAL (mental fog), COORDINATION ABNORMAL (coordination problems), ORTHOSTATIC HYPOTENSION (head rushes), CREPITATIONS (crackling), EYE MOVEMENT DISORDER (Eyes not following finger test) and DIZZINESS (Dizziness). At the time of the report, HALLUCINATIONS, MIXED (audio and visual hallucinations) and DIARRHOEA (diarrhea) had resolved, HYPOTENSION (low blood pressure), EAR PAIN (earache), FEELING ABNORMAL (mental fog), COORDINATION ABNORMAL (coordination problems), ORTHOSTATIC HYPOTENSION (head rushes), CREPITATIONS (crackling) and EYE MOVEMENT DISORDER (Eyes not following finger test) had not resolved and DIZZINESS (Dizziness) outcome was unknown.            The arm that the patient received each dose was not confirmed.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
heart attack; Heart palpitations elevated; Heart rate went high; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MYOCARDIAL INFARCTION (heart attack), PALPITATIONS (Heart palpitations elevated) and HEART RATE INCREASED (Heart rate went high) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDIAL INFARCTION (heart attack) (seriousness criteria hospitalization and medically significant), PALPITATIONS (Heart palpitations elevated) (seriousness criterion hospitalization) and HEART RATE INCREASED (Heart rate went high) (seriousness criterion hospitalization). At the time of the report, MYOCARDIAL INFARCTION (heart attack), PALPITATIONS (Heart palpitations elevated) and HEART RATE INCREASED (Heart rate went high) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: high (High) High.         Other concomitant product include high blood pressure medication. Treatment information was not reported.  Action taken with mRNA-1273 in response to the event was Not Applicable  Company Comment:  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Fever, admitted to Hosp.- went up to 104 degrees- possible seizure(parent reported twitching), then to normal temperature.
1 hr after vaccine had intractable emesis, nausea, chills, sweating; presented with dehydration next day and sent to emerg. dept for rehydration.
This spontaneous prospective pregnancy report was received from a physician refers to a 24 year old female patient. Patient's pertinent medical history and drug reactions were unspecified. On 11-DEC-2014 the patient was vaccinated with dose 1 of GARDASIL series. Concomitant medications were reported as prenatal vitamins. On an unknown date, the patient experienced exposure during pregnancy as she became pregnant shortly after administration of GARDASIL. On an unknown date, patient sought medical attention and visited physician's office. On an unknown date urine human chorionic gonadotropin (HCG) and serum HCG tests were performed. The LMP and EDD were not known. Outcome of the adverse event was reported as unknown. No product quality complaint (PQC) was involved. The causality was unspecified. Additional information has been requested.
Rec'd zoster vaccine 2/3. Reported irritation at injection site at 27 hours. Reported swelling and rash at 48 hrs. Seen by PA 4 days after and noted 8cm x 8cm wheal with vesicular center (2 x 5 cm) and continues to itch.
Vaccine expired 11/30/2022 - no reactions to vaccine, no treatment required. Patient tolerated vaccine without issue.  Unable to call patient after discovering the vaccine was expired. There is not direct phone number or email in patient chart.
missed second dose of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed second dose of vaccine) in a female patient of an unknown age 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 (missed second dose of vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed second dose of vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported by the reporter. No treatment medications were provided by the reporter.
Woke the morning after vaccination with pain throughout body (Saturday the 13th). Sunday pain level had increased. Monday (Feb 15th) pain increased to the point of being  unable to move or get out of bed. The only parts of the body not in high levels of pain are the lower arms. To see a doctor it would require an ambulance as the pain makes it impossible to move
beginning 3-4 days p/vax pt had myalgia, mild temp elevation 99+;
At 1 1/2hrs after receiving vaccine, my lower left lip, on left side only, got tingly and swelled.  My throat tightened and started to swell, but I could still get air.  This was mild swelling, but en; At 1 1/2hrs after receiving vaccine, my lower left lip, on left side only, got tingly and swelled.  My throat tightened and started to swell, but I could still get air.  This was mild swelling, but en; At 1 1/2hrs after receiving vaccine, my lower left lip, on left side only, got tingly and swelled.  My throat tightened and started to swell, but I could still get air.  This was mild swelling, but en; At 1 1/2hrs after receiving vaccine, my lower left lip, on left side only, got tingly and swelled.  My throat tightened and started to swell, but I could still get air.  This was mild swelling, but en; This is a spontaneous report from a contactable consumer or other non hcp. A adult Non pregnant female (Reported as 49 years) patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 15Mar2021 13:15 (Batch/Lot Number: En6206) as DOSE 1, SINGLE for covid-19 immunization. The patient Medical history included hypertension, blood cholesterol increased, palindromic rheumatism, Hay fever Allergies all from an unknown date and unknown if ongoing. There were no concomitant medications.  Patient had no other vaccine in four weeks . Patient was not tested Covid prior or post vaccination. Patient had known allergies known sensitivities, but not allergies. Patient had medications in two weeks. On 15Mar2021 1 1/2hrs after receiving vaccine, Patient experienced lower left lip, on left side only, got tingly and swelled ,throat tightened and started to swell, but patient could still get air. This was mild swelling, but enough for concern. Patient immediately took 1, 25MG Benadryl Liqui Gel, and continued that dosing for almost 48hrs. Adverse event start time was 14:30.  It was reported that No treatment for AE. She also went back to vaccine observation area, and contacted Primary care Dr via patient portal messaging. Patient Also had another episode on 07Apr2021 woke up in middle of night with same symptoms & took Benadryl again. The outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.
She received the first dose of the Pfizer COVID-19 vaccine on 3/25, and had some lip and tongue swelling and vocal changes with wheezing within 15 minutes of receiving the vaccine.  She was treated with benadryl and albuterol and sent home after improvement.  After going home, continued to have some lip/throat swelling. She then presented to local hospital with worsened symptoms, treated with benadryl and steroids, given a script for prednisone, and sent home.  She did not fill the prednisone script initially, but had some prednisone (unknown strength) at home and took a pill.  The following morning (3/26), she continued to have throat and lip swelling and began to develop some dyspnea. Due to these worsening symptoms, she came to ED.  She received a total of 5 doses of IM epinephrine (1734, 1938, 2010, 2320, 0017) along with IV pepcid and IV solumedrol for persistent subjective throat swelling, dyspnea, and difficulty tolerating secretions.  She was admitted to the ICU for close monitoring of symptoms and consideration of an epinephrine drip, but did NOT require this.  In the morning of 3/27, she noted substantial improvement in symptoms of tongue/lip swelling, improved wheezing, dyspnea, and dysphagia. Still with some mild hoarseness that she attributes to cough, also improving.
Awakened at about 1:00 A.M with painful arm.  Pain has continued  until now.  Also chills and   nausea.  Fever reached 100, subsequently dropping to  98.
Sweats, chills, lower back pain, weak, sleeping all day, diarrhea, feverish feeling in left arm.
Approximately 15 minutes post immunization, wheal approximately 2.5 cm just above MMR injection site with erythema extending 10 cm around area.  Ice applied .25ml Benadryl given IM above site.  Wheal subsided in 15 min post Benadryl.  Erythema diminished also evaluated by EMT.  Mom refused transport child doing well when left clinic.  Crying throughout.  No respiratory distress.
left arm is painful where she got the vaccine; left arm is red where she got the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (left arm is red where she got the vaccine) and VACCINATION SITE PAIN (left arm is painful where she got the vaccine) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced VACCINATION SITE ERYTHEMA (left arm is red where she got the vaccine). On 20-Apr-2021, the patient experienced VACCINATION SITE PAIN (left arm is painful where she got the vaccine). At the time of the report, VACCINATION SITE ERYTHEMA (left arm is red where she got the vaccine) and VACCINATION SITE PAIN (left arm is painful where she got the vaccine) outcome was unknown.        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 reported.  No treatment information was provided.
Swelling and irritation of my left eye. 2nd day worsening condition, pain with blinking, under eye swelling (lite swelling)