chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After the second dose I started to have sporadically. I thought that was some allergies. I went to the doctor, did some exams and everything is normal.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Feb2021 14:00 (Lot number: EN6203) at the age of 45 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Surgical menopause and hypercholesterolemia" (unspecified if ongoing); "Surgical menopause and hypercholesterolemia" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Covid19 vaccine (DOSE 1, SINGLE, Batch/Lot No: EL9261, Location of injection: Arm Left), administration date: 22Jan2021, for COVID-19 IMMUNIZATION. The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "After the second dose I started to have sporadically. I thought that was some allergies. I went to the doctor, did some exams and everything is normal.". The event "after the second dose i started to have sporadically. I thought that was some allergies. i went to the doctor, did some exams and everything is normal." was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of hypersensitivity.  Additional information: After the second dose I started to had sporadically. I thought that was some allergies. I went to the doctor, did some exams and everything was normal. 4 days after the third dose , I have strong hives in my entire body: legs, arms, belly and back. The hives didn't go way. I search and I found person with the same hives due vaccine allergies. The events result in doctor or other healthcare professional office/clinic visit. The events treatment was Zyrtec. The patient had not received any other vaccine prior to the COVID vaccine. The patient had not been tested since the vaccination. The patient had no known allergies. Follow-up attempts are completed. No further information is expected.
heart palpitations; This case was reported by a consumer and described the occurrence of palpitation in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced palpitation. On an unknown date, the outcome of the palpitation was not recovered/not resolved.   It was unknown if the reporter considered the palpitation to be related to Shingrix.  Additional details provided were as follows: The case was reported by patient himself/herself. Age at vaccination was not reported. The patient received a dose of Shingrix vaccine and experienced heart palpitations. The patient asked to be in touch with a nurse at GlaxoSmithKline (GSK) to discuss his/her heart palpitations. Follow-up would not be possible as no contact details provided.
Hives. Full body. Violent itching. Completely inflamed skin.   No breathing issues.
Eye irritation then numbing of face and slurred speech.  Went to ER, was put on STROKE ALERT, received CT Scan of head. Result diagnoses; BELLS PALSY.
First time having high dose Flu vaccine: first time increased reaction. Soreness at site x 3-4 days, malaise 3-4 days, nausea 3-4 days. If I am forced to get this high of dose through insurance due to age, I will take my chances with the flu!
ADULT OBSTRUCTIVE SLEEP APNEA ACUTE ON CHRONIC HYPERCAPNIC RESPIRATORY FAILURE
sick; drop in blood pressure when up standing; feels like her heart is racing; This spontaneous case was reported by an other caregiver and describes the occurrence of ORTHOSTATIC HYPOTENSION (drop in blood pressure when up standing), PALPITATIONS (feels like her heart is racing) and ILLNESS (sick) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included HYDROCHLOROTHIAZIDE and TRIAMTERENE for Blood pressure management.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced ORTHOSTATIC HYPOTENSION (drop in blood pressure when up standing) and PALPITATIONS (feels like her heart is racing). On an unknown date, the patient experienced ILLNESS (sick). At the time of the report, ORTHOSTATIC HYPOTENSION (drop in blood pressure when up standing), PALPITATIONS (feels like her heart is racing) and ILLNESS (sick) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Blood pressure measurement: decreased (Low) decreased on standing.     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 treatment information was provided.   This case was linked to MOD-2021-116517 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Follow up received and contains information on second dose event details
On Friday the 11/20 woke with terrible muscle aches. Swelling in arm at injection site. Warm and itchy. A little bit of chill. Fatigue. Unable to eat. Achy. 4 inches of redness on injection site that radiated to elbow. Started eating soup on Sunday. Redness is better today, but still itchy. Have been using ice packs for the itching.
Severe debilitating fatigue that began the day after the vaccine (as expected), but has persisted; fatigue is so severe that I have had to stop working.  I am a physician doing telemedicine
No side effects reported; HCP calling to report AE for patient who received improperly stored PROQUAD; This spontaneous report was received from other health professional, regarding to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.  On 04-OCT-2023, the patient was vaccinated with an improperly stored dose of with improperly storage dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) subcutaneous injection, for prophylaxis (lot number: 05-JAN-2025, which has been verified to be valid, expiration date not reported, but upon internal validation established as 05-JAN-2025) (strength, dose, vaccination scheme, route of administration, and anatomical site of injection were not reported).   Administered dose was stored at a temperature of -9.8 degrees Celsius (C), during a time frame of 12 minutes (product storage error). There was no previous temperature excursion.   No additional adverse events were reported in the patient.; Sender's Comments:  US-009507513-2310USA007934:
Patient received vaccine and said it was painless. She was accompanied by her mother, shortly in to her 15 minute waiting period her mother approached and said the patient felt light headed. I asked patient to remove her mask and assessed for any swelling of the lips or the face. Patient stated she did not have any issues breathing but felt very faint. Her eyes were very dilated, and she wanted to lay down. So we assisted patient to the floor, called Code White and 911. I stayed with patient as she lay down, she began to recover, but still looked very pale. I continually assessed patient for anaphylaxis, but patient reported no pain in injection site or issues breathing. Paramedics arrived and assessed patient,  BP was normal, blood sugar was in the low normal range, paramedics determined that issue was not related to vaccine, but that she was dehydrated and had not eaten, which exacerbated the light headedness.
Legs felt silly, c/o Rt knee pain with swelling. Pt was given NAPROSYN.
Syncope. Rc'd immunizations. Upon standing pt felt dizzy, nauseous and fell to floor. Soreness Lt cheek from fall. Checked BP. Gave him some water. Waited 10-15 more minutes. Patient felt fine to leave.
Information has been received from a physician concerning a male between the ages of 4 & 5 who in approximately OCT-2007 (month and half ago) was vaccinated subcutaneous with a second 0.5 ml dose of VARIVAX (Oka/Merck). In approximately OCT-2007 (after receiving his second dose) the patient developed urticaria followed by lesions and was admitted to the hospital. At the time of the report the patient's status was unknown. A product quality complaint was not involved. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 56-year-old male patient who received SHINGRIX for prophylaxis. On 23rd February 2019, the patient received SHINGRIX. On 24th February 2019, 1 days after receiving SHINGRIX, the patient experienced injection site pain, pain in arm and axillary pain. On 25th February 2019, the patient experienced injected limb mobility decreased. On an unknown date, the outcome of the injection site pain, pain in arm, injected limb mobility decreased and axillary pain were unknown.  It was unknown if the reporter considered the injection site pain, pain in arm, injected limb mobility decreased and axillary pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid. The patient developed injection site pain the day after the vaccination. He developed a pain that radiates from his armpit to his wrist on  25th February 2019 (Monday).
I had difficulty breathing; lowoxygen level; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (I had difficulty breathing) and OXYGEN SATURATION DECREASED (lowoxygen level) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (I had difficulty breathing) (seriousness criterion hospitalization) and OXYGEN SATURATION DECREASED (lowoxygen level) (seriousness criterion hospitalization). At the time of the report, DYSPNOEA (I had difficulty breathing) and OXYGEN SATURATION DECREASED (lowoxygen level) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Oxygen saturation: low oxygen level (Low) Low oxygen level.         No concomitant medications were provided by the reporter. No treatment information was provided by the reporter. Patient was admitted to hospital after 2nd Moderna shot because the patient had difficulty breathing and low oxygen level. Pulmonologist wrote diagnosis as side effect of shot.  Company comment: This case concerns a patient of unknown age and gender, with no medical history reported, who experienced the unexpected events of dyspnoea and oxygen saturation decreased, which required hospitalization. The events occurred on an unknown date after the second dose of mRNA-1273. As reported, patient was admitted to hospital after 2nd Moderna shot because the patient had difficulty breathing and low oxygen level. Pulmonologist wrote diagnosis as side effect of shot. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a patient of unknown age and gender, with no medical history reported, who experienced the unexpected events of dyspnoea and oxygen saturation decreased, which required hospitalization. The events occurred on an unknown date after the second dose of mRNA-1273. As reported, patient was admitted to hospital after 2nd Moderna shot because the patient had difficulty breathing and low oxygen level. Pulmonologist wrote diagnosis as side effect of shot. The benefit-risk relationship of mRNA-1273 is not affected by this report.
I had the same shots last year - same location, both together, and only experienced localized pain. This year my arm swelled by that evening, pain was such that I couldn't put any weight on or touch that area; it also reddened with what looked like a rash;  there was some itchiness; I had fever of 101 degrees two days later. On 3rd day symptoms abated.
rash; This is a spontaneous report received from a contactable reporter(s) (Physician) for a Pfizer sponsored program.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious), outcome "not recovered", described as "rash".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
bruise (1.5cm; has persisted 5 months), soreness, redness, & raised area @ inj site;
Information has been received from a physician concerning a 16-month-old female who on 25-APR-2006 was vaccinated SC with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (Lot # 649233/0996P). On 14-MAY-2006 the patient developed clinical signs of mumps. She had a fever of 102 degrees, one episode of vomiting. "corotid swelling on one side for four days", elevated IgM levels", and "elevated amylase levels". It was noted that the family traveled from 17-APR-2006 through 22-APR-2006. Unspecified medical attention was sought. The outcome was reported as recovering. No additional information was provided. There was no product quality complaint. Additional information has been requested.
Redness all over body; Scratch all over the body; Rashes all overy body; This spontaneous case was reported by a nurse and describes the occurrence of ERYTHEMA (Redness all over body), SCRATCH (Scratch all over the body) and RASH (Rashes all overy body) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced ERYTHEMA (Redness all over body), SCRATCH (Scratch all over the body) and RASH (Rashes all overy body). At the time of the report, ERYTHEMA (Redness all over body), SCRATCH (Scratch all over the body) and RASH (Rashes all overy body) 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.   In the FU she stated the adverse effects from the first dose lasted about 3 weeks and then went away.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Follow-up received on 05-AUG-2021 and outcome was updated.
This case was reported by a nurse and described the occurrence of petechiae in a 27-year-old female patient who received hepatitis A inactivated & hepatitis B recombinant vaccine Twinrix. On 16 September 2003, the patient received the first dose of Twinrix (lot HAB235A4) with no adverse events. Approximately one month later, on 16 October 2003, the patient received the second dose of Twinrix (lot HAB235A4) in her left arm. Approximately 30 minutes following the second administration of Twinrix, on 16 October 2003, the patient experienced petechiae, urticaria and itching. The site of the reaction was not specified by the reporter. The reporter noted that concurrent to the second administration of Twinrix, the patient was being treated with an unspecified antibiotic for a urinary tract infection. The patient was examined at an "acute care clinic" and was treated with cetirizine hydrochloride (Zyrtec) and topical hydrocortisone. The events resolved on 17 October 2003. The immunization series with Twinrix was discontinued. The nurse considered the events to probably be related to vaccination with Twinrix.
Narrative:  79-year-old female with a past medical history of hypertension, morbid obesity, COPD and tobacco abuse/dependence who presented to the hospital with a chief complaint of shortness of breath and cough. Patient states she started feeling bad last week and states that it all started with a cough. Patient states she came to emergency department because she was having more difficulty breathing. Patient was noted to be satting in the 90s on arrival to the emergency department but did drop to 87% with ambulation. Patient was also noted to have significant rhonchi and wheezing at the bedside so we were consulted for admission. Patient states she has been vaccinated.
From telephone contact received on 6/19/02, it was reported that a 27 year old female received TD ADS vaccine on 6/24/02. Within 24 hours post vaccination, patient developed pain, redness and swelling at injection site, also numbness in entire arm. Patient seen in doctor's office on 6/26/02 and treated. Reactions completely resolved.
Several hours after the vaccine was administered, patient experienced hives all over his torso. Reaction was mild and self-limiting. Patient was monitored during first 15 minutes after vaccine administration, but no signs/symptoms of allergic reaction occurred during that time. No other adverse effects occurred besides the hives. Patient had received flu vaccine in the past, but it was several years ago. No previous reactions to the flu vaccine or any other vaccines.
pt states that w/in 2 hrs of receiving the flu vax had a rash on arm where vax was administered & itched; eyes were swollen & began to have bad h/a;
Sore arm; This is a spontaneous report from a contactable consumer (patient's mother). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient's mother reported that her daughter received the vaccine and experienced a sore arm. The clinical outcome of the event was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Vitiligo, recently diagnosed 1/11/22 . Lack of pigmentation began initially during summer, progressing to cover larger areas (inside of both arms)
same area and is quite painful; 5th case of Shingles; Suspected vaccination failure; first episode of Shingles occurred in October 2021; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 13-FEB-2020, the patient received the 2nd dose of Shingrix. On 15-DEC-2019, the patient received the 1st dose of Shingrix. In OCT-2021, between 1 and 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: first episode of Shingles occurred in October 2021). On 27-AUG-2023, the patient experienced shingles (Verbatim: 5th case of Shingles). On an unknown date, the patient experienced pain (Verbatim: same area and is quite painful).  The outcome of the vaccination failure, shingles, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, shingles and pain to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure, shingles, shingles and pain to be related to Shingrix and Shingrix.   Additional Information: GSK receipt date: 28-Aug-2023 The patient stated she had her 1st and 2nd Shingrix vaccination and had 5 cases of Shingles beginning in 2021. The patient had first episode of Shingles occurred in October 2021.   She stated that her 5th case of Shingles started 27 August 2023.  The location of the Shingles rash with each outbreak had been on her lower back in the same area and was quite painful. This case was considered as suspected vaccination failure as details regarding laboratory test confirming shingles were unknown at the time of reporting. The reporter consented to follow up.
Headache; This is a spontaneous report from a contactable consumer (patient). A 49-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown) via an unspecified route of administration in the left arm, on 01Mar2021 (at 12:00 ) as 1st dose single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 02Mar2021, the patient experienced headache. The patient did not receive any treatment for headache. On 05Mar2021, the outcome of the event was reported as recovering.   No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
rash on the left collar bone/rash spread down to their chest reaching their breasts/rash spread across their chest, from shoulder to shoulder/rash spread up to their neck/rash runs up the sides of their neck up to behind their ears; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on the left collar bone/rash spread down to their chest reaching their breasts/rash spread across their chest, from shoulder to shoulder/rash spread up to their neck/rash runs up the sides of their neck up to behind their ears) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 23-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Aug-2021, the patient experienced RASH (rash on the left collar bone/rash spread down to their chest reaching their breasts/rash spread across their chest, from shoulder to shoulder/rash spread up to their neck/rash runs up the sides of their neck up to behind their ears). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, RASH (rash on the left collar bone/rash spread down to their chest reaching their breasts/rash spread across their chest, from shoulder to shoulder/rash spread up to their neck/rash runs up the sides of their neck up to behind their ears) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported.