chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Did not get the second dose and it's been more than 36 days from the first; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Did not get the second dose and it's been more than 36 days from the first) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jul-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Did not get the second dose and it's been more than 36 days from the first). On 15-Jul-2021, PRODUCT DOSE OMISSION ISSUE (Did not get the second dose and it's been more than 36 days from the first) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was provided.
Colitis ulcerative aggravated; blood sugar increased; MARKETING PROGRAM NOT AVAILABLE  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4180185-00 (Mfr Control No.).  A 60 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown). The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: COLITIS ULCERATIVE (medically significant), outcome "recovered", described as "Colitis ulcerative aggravated"; BLOOD GLUCOSE INCREASED (non-serious), outcome "not recovered", described as "blood sugar increased". The action taken for adalimumab was unknown.  The reporter considered "colitis ulcerative aggravated" and "blood sugar increased" related to bnt162b2. The reporter causality for blood sugar increased was a reasonable possibility and for colitis ulcerative aggravated was not reported for the suspect HUMIRA.  Clinical information: The patient had no known allergies. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided, a possible causal association between the reported events, Ulcerative colitis, blood glucose increased and the suspect product BNT162B2 cannot be totally excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
C/O chills for past week, shaky and feverish "not feel well since got the shot." Did not see MD. No other vaccines taken.
Date of HPV vaccine #2,8/11/08 developed pain, swelling and erythema at injection site of left arm. Next two days at injection site sloughing of epidermal layer and development of a sore at injection site. Now healing over but with residual hyperpigmented scar involving ares of injection and sore. Date of initial HPV vaccine 6/11/08.
And, um, because the pharmacist gave it, um, too low on my arm, I believe she missed the deltoid muscle completely and I reacted; I reacted with a large red, um, warm lump for three days on my arm; Warm lump for three days on my arm; I reacted with a large red, um, warm lump for three days on my arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE WARMTH (I reacted with a large red, um, warm lump for three days on my arm), VACCINATION SITE MASS (Warm lump for three days on my arm), VACCINATION SITE ERYTHEMA (I reacted with a large red, um, warm lump for three days on my arm) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (And, um, because the pharmacist gave it, um, too low on my arm, I believe she missed the deltoid muscle completely and I reacted) in a 70-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3030536) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Sep-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Subcutaneous use) .5 milliliter. In 2023, the patient experienced VACCINATION SITE WARMTH (I reacted with a large red, um, warm lump for three days on my arm), VACCINATION SITE MASS (Warm lump for three days on my arm) and VACCINATION SITE ERYTHEMA (I reacted with a large red, um, warm lump for three days on my arm). On 28-Sep-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (And, um, because the pharmacist gave it, um, too low on my arm, I believe she missed the deltoid muscle completely and I reacted). In 2023, VACCINATION SITE WARMTH (I reacted with a large red, um, warm lump for three days on my arm), VACCINATION SITE MASS (Warm lump for three days on my arm) and VACCINATION SITE ERYTHEMA (I reacted with a large red, um, warm lump for three days on my arm) had resolved. At the time of the report, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (And, um, because the pharmacist gave it, um, too low on my arm, I believe she missed the deltoid muscle completely and I reacted) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Subcutaneous use), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Patient had Moderna 1st dose on 11 Feb 2021 (lot number 011M20A), Moderna 2nd dose on 11 Mar 2021 (lot number 048A21A), Moderna booster on 28 Oct 2021 (lot number 046B21A), Moderna 4th dose on 20May2022 (lot number 057M21A) and Moderna 5th dose on 28Nov2022 (lot number 083B22A). Pharmacist vaccinated the patient low on her arm and she believes that the deltoid muscle was missed completely. She was wondering now if that vaccination was effective or not. No treatment medication reported.   Most recent FOLLOW-UP information incorporated above includes: On 26-Oct-2023: Follow-up information included no new information.
Breakthrough case admission after 2 vaccines Pfizer m3/31/21 lot# EW0150;  Pfizer 4/21/21 lot# ER8735
Swollen lymph nodes above and below clavicle and side of neck on injection site side (left arm); This is a spontaneous report from a contactable nurse, the patient. A 52-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9810) via intramuscular route of administration in the left arm on 11Feb2021 at 09:00 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. The patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via intramuscular route of administration on 03Mar2021 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. Medical history included hyperlipidemia and sulfonamide allergy (Allergies to medications, food, or other products: sulfa). Concomitant medications included atorvastatin calcium (LIPITOR) from an unknown date and unknown if ongoing for an unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Feb2021 the patient experienced swollen lymph nodes above and below clavicle and side of neck on injection site side (left arm). The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swollen lymph nodes above and below clavicle and side of neck on injection site side (left arm) was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
headaches; loose the smell; she had pain all over her body; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received first dose of bnt162b2 (BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 24Mar2021 as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter stated that she was administered with the first dose of the vaccine on 24Mar2021 and the next day on 25Mar2021 she started to lose the smell, she had pain all over her body and headaches. The Consumer reports that she and her family were tested for COVId-19 the day the vaccine was administered, and the results were negative. The Consumer reports that the symptoms have been lowering down in intensity since the administration of the vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 24Mar2021 tested for Covid-19 the day the vaccine was administered, and the results were negative. The outcome of the events was reported as recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021377800 same drug and event, different patient
pt recv vax 14MAY97 & 2:00 & 5PM pt returned to MD office w/an upset stomach, lightheadedness, flushing & vomiting (once);pt was diaphoretic but vital signs were stable;pt then rested for 30min, refused emergency care @ local hosp & went ho
Information has been received from a nurse practitioner concerning a 24 year old female who vaccinated the first dose of GARDASIL on an unspecified date and second dose of GARDASIL in July 2008. Concomitant therapy included unspecified birth control. The nurse reported the patient who received GARDASIL developed arm discomfort or pain after each dose. After the first dose of GARDASIL, the patient had discomfort and sensitivity around the injection site. It lasted for a short time. After the second dose of GARDASIL, the patient had pain at the vaccinated arm. The arm was sensitive for 2 months and now resolved. Additional information has been requested.
Patient developed a rash and swelling of face 3 days after vaccine administered. Rash and swelling progressed over 2 days and fever up to 104.7 developed. Diagnosed with serum sickness and was started on prednisone and BENADRYL and then ZYRTEC.
Information has been received from a consumer concerning her daughter who on 18-Apr-2008 was vaccinated with the first 0.5ml dose of GARDASIL. After getting the first dose the patient experienced joint pain in back, hip and knees. On 16-Jul-2008 received the second dose of HPV vaccine and experienced fainting, dizziness, headache, trouble comprehending in school and joint pains. At the time of reporting the mother's patient stated that daughter still had headaches and dizziness. The patient sought unspecified medical attention. Additional information has been requested.  6/19/09 Medical records received DOS 4/4/08 to 5/08/09. Assessment: Insomnia, weight loss, otitis externa acute, depression with anxiety Patient became pale and c/o blurred vision, dizziness. Difficulty walking, lightheaded. Later otalgia, URI. Aching joints - hip, back, knee. Headache, abdominal pain, anxiety. Coughing, nose congestion with headaches, postnasal drip, sore throat. acute sinusitis, dyspnea. Hyperactivity. PTSD. ICD-9 Codes: 780.52, 783.21, 380.10, 300.4, 461.9 786.2 786.09, 784.0 789.07, 300.00, 995.20, 780.4, 388.70, V65.40, 465.9, V04.89
The client developed a low grade fever (100-101 degrees F) at 1600 on 10/18/2018. She described feeling "icky". The client was given ibuprofen shortly after. By the AM on 10/19/2018 the injection site area was swollen. The client received BENADRYL at this time. She felt better in the AM of 10/19/2018, however the arm was swollen to baseball size. The arm was warm to the touch and extremely itchy for the client. These symptoms lasted throughout the next couple days. The arm remained slightly swollen for a week following the immunization injection.
LMP, 03/06/2021 Miscarriage, 06/2021 Prolonged bleeding since Sep 2021
FACE PUFFINESS, TINGLING SENSATIONS ON LIPS AND TONGUE, THROAT SCRATCHINESS, LIGHTHEADES FEELING. PATIENT USED HER OWN EPIPEN AND INJECTED HERSELF ON HER RIGHT UPPER THIGH. AFTER FEW MINUTES SHE EXPERIENDED RACING HEART RATE, HEAT, SHAKE. THE PHARMACIST TOOK HER BLOOD PRESSURE WHICH WAS VERY HIGH, AND CALLED 911. PARAMEDICS SHOWED UP AND TOOK HER TO THE LOCAL EMERGENCY ROOM. PATIENT CALLED LATER IN THE DAY , SHE WAS IN A BETTER CONDITION.
I felt as if i needed to poop; rapid heartrate; difficulty catching my breath; my face became flush; my face became flush with reddish rash; shakiness/trembling; strange taste in my mouth; tongue started to swell; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19  VACCINE, Solution for injection; lot number: EP6955 and expiration date: not reported), via an unspecified route of administration, in Left Arm, on 06Mar2021 at 11:30 (at the age of 34-year-old) as DOSE 1, SINGLE for covid-19 immunization at Pharmacy or Drug Store.  The patient had allergy to Reglan. The concomitant medication included Elderberry with VitC&Zinc Daily. The patient was not pregnant at time of vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID -19 vaccine. The Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. On 06Mar2021 at 11:30, Immediately upon receipt of  first dose, patient felt as if she needed to poop, had rapid heartrate, difficulty catching breath, face became flush with reddish rash, had developed shakiness/trembling and had a strange taste in mouth, tongue started to swell and patient immediately took 25mg of Benadryl. The outcome of the events was recovered in Mar2021.  No follow-up attempts are Possible. No further information is expected.
In August of 2021, I would forget things when I was speaking. I was very frustrated. I could describe the word, tell the definition, but not tell you the word. This continued through October, I went to my primary care doctor, who referred me to a Neurologist. I went to see the Neurologist, who did some verbal tests. She sent me for an MRI. I have not been back. The doctor wants me to have a sleep study. It has gotten a lot better.
PENTACEL was administered to patient, DTaP was the only vaccine that was needed, so extra dose of polio & HIB was given, parents were notified, no adverse reaction.
Normal soreness the 1st 3 days. Extreme local pain returned on 5/12/01 and 5/13/01. Saw doctor on 5/14/01 with follow-up on 5/21/01; taken antibiotic and Ultram for pain and doing better as of 5/19/01 or so but still some pain.
Paresthesia in left arm, left leg & foot, right foot, and right side of face
Severe leg pain first, then trouble breather. Shortness of breath and tightness in chest. Thought it was severe congestion... delayed going to the ER. Finally went in due to vomiting trying to get  breath. Had LAD 90% blocked and blockage in the right leg still in hospital receiving treatment. Will Catheter scope the right leg to very clots and severity.
Information has been received from a registered nurse referring to a 33 year old male patient. There were no pertinent medical history or drug reaction/allergies. Concomitant therapy included unspecified vitamins. On 04-APR-2018, the patient was vaccinated with the first dose of VARIVAX (lot # N022983 expiration date 23-AUG-2019, dose and route not reported) for prophylaxis. The vaccine was reconstituted with sterile diluent (manufacturer unknown) (lot #, expiration, dose and route not reported). It was reported that no documentation for titers, the patient had never had VARIVAX.On approximately 18-APR-2018, about 2 weeks after VARIVAX administration, the patient experienced "a rash" on an unspecified region of the body described as "sores" and "scabs". He also experienced "itching" at the rash site. The patient sought medical attention. The nurse reported as treatment, the patient was prescribed VALTREX and an unspecified topical prednisone. No labs were performed. The symptoms had resolved on an unspecified date in April 2018 (described as "a couple of days after treatment"). The causality between the events and suspect therapies were not provided. No further clarifying information was provided.
at 6:30pm, on playground w/ siblings, laid down crying for mom;brother thought crying for slide;picked pt up & help go down slide;collapsed/fainted,may have hit head;took to par;was limp & shallow breathing;taken to hosp;had cardiac arrest;
After having my second Moderna Vaccine I had the usual side effects of fever, chills, arm pain etc. in addition to that it has caused a significant delay in my period along with significant cramping and bloating and discomfort.  I am very regular on my cycles and am NOT pregnant as am sterilized. The Moderna Vaccine has caused chamgeses and delays to my menstruation.
Information has been received from a physician concerning a female (age unknown), who was vaccinated with a dose of GARDASIL.  Subsequently, the patient experienced seizure like symptoms.  The patient sought unspecified medical attention from the physician.  The physician reported that the patient was not going to continue the rest of the series.  The patient recovered on an unspecified date.  The physician considered the seizure like symptoms to be disabling.  Additional information has been requested.
Progressed to very sick; Temperature 99.5; head pain; Sore left arm first 2 days; depression; confusion; vertigo; body aches; dry eyes; back pain; light sensitivity; migraine; hot / cold; hot / cold but mostly very cold; no hunger; Brain fog; no thirst at all; chills; nausea; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: en6208), via an unspecified route of administration in the left arm on 13Mar2021 at 14:15 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to shellfish (only on a blood test), penicillin and sulfa. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient received other unspecified medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received escitalopram oxalate (LEXAPRO) and experienced drug allergy. Since the vaccination, the patient had been tested for COVID-19. On 14Mar2021 at 07:00, the patient had sore left arm first 2 days. Then, on unknown dates in Mar2021, the patient experienced brain fog, confusion, vertigo, nausea, body aches, dry eyes, depression, back and head pain, light sensitivity, migraine, no hunger or thirst at all and hot / cold but mostly very cold with chills. On 18Mar2021 (Thursday), the patient missed work for the back and head pain. On 20Mar2021 (Saturday), the patient progressed to being very sick. Since 20Mar2021 to 24Mar2021 (reported as today), the temperature was 99.5. The patient missed the work from 22Mar2021 to 24 Mar2021 (at least). The events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab test on 22Mar2021 which included PCR with test type of nasal swab and the test result was negative. The patient received telemedicine prescribed nausea medication for the event of nausea. The clinical outcomes of the events sore left arm first 2 days, brain fog, confusion, vertigo, nausea, body aches, dry eyes, depression, back pain, light sensitivity, migraine, no hunger or thirst at all, hot/cold, hot / cold but mostly very cold with chills, chills, head pain, progressed to very sick and temperature 99.5 were not recovered at the time of the report.   No follow-up attempts are needed. No further information is expected.
No additional AE was reported.; a Temperature Excursion drug of VARlVAX have been administered to patient; This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender.  Information regarding medical history or concomitant medications was not reported.  On an unspecified date in 2021 (reported as: between 16-JAN-2021 and 15-FEB-2021) the patient was vaccinated with an incorrectly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # T022315 and Expiration Date 30-JUN-2022 (strength, dose, and route of administration were not provided), for prophylaxis. Temperature excursions were at -14.6°C and -13.6°C for 20, and 40 minutes, respectively. The reporter stated that none of the patients had reported any side effects. I t was reported that there was no previous excursion, and it was noted because of a data logger.   This case is linked to case 2102USA009497, via same reporter link.
16 hours, post vax, pt had a 20 minute seizure followed by about 15 minutes of post- ictal state and then a 30 second seizure. Both tonic/clonic grand mal. Afebrile both tactile and highest ER temperature was 99.7F. Had received DTAP, IPV, HIB-Hep-B, Prevnar on 8/2/01 without incident.
Swelling of the face; Rash; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (primary immunization series complete: unknown manufacturer), for COVID-19 immunization. The following information was reported: SWELLING FACE (non-serious), outcome "unknown", described as "Swelling of the face"; RASH (non-serious), outcome "unknown". The events "swelling of the face" and "rash" required physician office visit. Additional information: Patient experienced swelling of the face and rash. Patient has a history of asthma and was sent to an allergist. Event took place after use of product. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.