chrisvoncsefalvay/vaers-outcomes huggingface dataset:
showing expire May 30, 2023 Administered expired vaccine; no adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (showing expire May 30, 2023 Administered expired vaccine) and NO ADVERSE EVENT (no adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 020H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (showing expire May 30, 2023 Administered expired vaccine) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (showing expire May 30, 2023 Administered expired vaccine) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (showing expire May 30, 2023 Administered expired vaccine).    Concomitant medication not reported.  Treatment medication not reported.
wait for 6 months after they healed. only have to be healed up; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included immune disorder (nos) (the patient had other immune issues).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The patient got these newer shingles shots. The patient had the first one. The patient reported that he/she was on 3rd bout since February. The patient was advised to wait for 6 months after they healed.  The patient could not get that many months in between. The patient wanted shingles to get healed up.
fever of 99.5 around 430pm (on a digital thermometer that usually reads 97.5-6, so it may actually be higher) took 200 mg motrin earlier (7am) for body aches/skin sensitivity/chills.  When I realized I had a fever I took another 200mg ibuprofin, applied cold pack to forehead will seek emergency room or urgent care if it doesnt go down in a couple hours
A febrile seizure 10 days after VARIVAX, Flu shot and Hepatitis A seen at ER at local hospital.
Discomfort; form as welts, bites, bumps, sores; red bump on right chest, abdomen, red flat dot; Covid; red spots on arm, chest, bites, bumps, sores; got vaccines, got shingles; shingles; This serious case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In OCT-2022, the patient received the 1st dose of Shingrix (unknown arm). In JAN-2023, the patient received the 2nd dose of Shingrix (unknown arm). In APR-2023, between 5 and 6 months after receiving Shingrix and between 2 and 4 months after receiving Shingrix, the patient experienced vaccination failure (Verbatim: got vaccines, got shingles) (serious criteria GSK medically significant), shingles (Verbatim: shingles) and red spotty rash (Verbatim: red spots on arm, chest, bites, bumps, sores). On an unknown date, the patient experienced discomfort (Verbatim: Discomfort), welts (Verbatim: form as welts, bites, bumps, sores), local swelling (Verbatim: red bump on right chest, abdomen, red flat dot) and covid-19 (Verbatim: Covid). The outcome of the vaccination failure, discomfort, welts, local swelling and covid-19 were unknown and the outcome of the shingles was not reported and the outcome of the red spotty rash was resolved.   It was unknown if the reporter considered the vaccination failure, shingles, discomfort, red spotty rash, welts, local swelling and covid-19 to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure, shingles, discomfort, red spotty rash, welts, local swelling and covid-19 to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 01-May-2023 The patient received his first Shingrix vaccine in October 2022, in an unknown arm and his second Shingrix vaccine in January 2023, in an unknown arm.  In April 2023, he first discovered a few raised red bumps on his right arm and one raised red bump on his right chest.  The reporter said couple days later there were about 6 raised red bumps on his right abdomen.  The patient states that there was no pain or itching.  He tested positive for Covid, so he went to the urgent care to receive medication for Covid and while there he mentioned to the doctor about the raised red bumps.  The doctor confirmed the raised red bumps were shingles.  The red raised bumps appeared before Covid was positive.  The doctor did not prescribe any medication for shingles.  The caller reports the all the praised red bumps had resolved or were just a red flat dot.  The reporter was very pleased he was spared the horrors of shingles pain. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Mom called on 1/28/00, stating pt had orange-sized red knot, 2" inferior to injection site. At assessment, 2 areas of erythema were noted 2" inferior, indurated & tender. Tx: warm soaks & antibiotics. Temp 102.
Patient developed a rash on her face, arms and upper back post vaccination per her report. Tele-visit conducted on 03/18/2021 rash was resolved.
The following day I began to have a very hard time breathing. It then got worse and I could not walk more than a few steps without having to sit down due to not being able to breathe along with chest pains. I am still having a hard time breathing. By Thursday I went to my doctor and he said that I had a severe upper respiratory infection.
diagnosed by M.D. Bells Palsy. Left side of face & eye paralyzed 12/26/2019 eye sight effected. Taping eye at night. Still no releaf. Started PT 2/17 & continuing 2x week. Purchased Tens Unit using 3x day. Mouth & muscles do not move Left eye droops & pain & trauma in eye
pt recv vax 6NOV95 & w/in 30min of vax pt devel a flushed face, hot cheeks & numbness of the lips;did not exp tightness in throat & recovered;
On 03/21/13, Pt evaluated at urgent care and reported onset of faint numbness in fingers and toes, and numbness in lower back and buttocks x 3 days. F/U w/ PCP. On 03/23/13, patient admitted via E/R , Pt treated with IV immunoglobulin x 5 days. LP confirmed Guillain Barre Syndrome.
felt "really tired" - fell asleep writing emails  which is not like her; arm hurt a 5 out of 10; felt "really tired" - fell asleep writing emails  which is not like her; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (felt "really tired" - fell asleep writing emails  which is not like her), PAIN IN EXTREMITY (arm hurt a 5 out of 10) and FATIGUE (felt "really tired" - fell asleep writing emails  which is not like her) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced SOMNOLENCE (felt "really tired" - fell asleep writing emails  which is not like her), PAIN IN EXTREMITY (arm hurt a 5 out of 10) and FATIGUE (felt "really tired" - fell asleep writing emails  which is not like her). At the time of the report, SOMNOLENCE (felt "really tired" - fell asleep writing emails  which is not like her), PAIN IN EXTREMITY (arm hurt a 5 out of 10) and FATIGUE (felt "really tired" - fell asleep writing emails  which is not like her) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-071307 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-071307:Husband case
Patient got shot around 5pm at the store. Stayed around 15 minutes in the store- no reaction.  Went home and stated she felt fine, sewed for a little while and around 7pm said her arm started to hurt.  The pain "kept her up all night" and continued to the next day.  Reported to the pharmacy the day after the shot to report pain.  In the pharmacy, she said it was very sore to touch.  I was able to palpitate the area.  Area seemed slightly warm and tight in comparison to other arm.  Limited in range of motion.
Information has been received from a physician referring to a 12 year old female patient. Information about concurrent condition, medical history and drug reactions/allergies were not provided. On 15-JUL-2014, the patient vaccinated with a first dose of GARDASIL (dose and route were unknown, lot # H020901, expiration date 05-JUL-2015) and VAQTA (dose and route were unknown, lot # J014584, expiration date 16-JAN-2016). No adverse effect was reported. On 17-SEP-2014, the patient vaccinated with a second dose of GARDASIL (dose and route were unknown, lot # K006095, expiration date 02-FEB-2016). On appropriately 08-OCT-2014 (reported as 3 weeks after administration), the patient had hives, joint swelling and urticarial with a fever. The patient saw at an unspecified allergist office on an unknown date and then at a medical institution on an unspecified date for treatment. Physician stated that the diagnosis was "post viral" and "not related to GARDASIL". The outcome of the aforementioned events was not provided. On 10-AUG-2016, the patient vaccinated with a third dose of GARDASIL (dose and route were unknown, lot # L020015, expiration date 16-AUG-2017) (drug use for unapproved schedule) and VAQTA (dose and route were unknown, lot # L023936, expiration date 15-MAR-2017) (drug use for unapproved schedule). On appropriately 31-AUG-2016 (reported as 3 or 4 weeks after administration), the patient had hives and joint swelling. The outcome of the hives and joint swelling (onset date of 31-AUG-2016) was unknown. The causality assessments between the events (onset date of 31-AUG-2016) and GARDASIL and VAQTA were not reported. Additional information has been requested.
Shingles outbreak.  Lasted 1 week.  Took anti-viral.  Resolved
After nearly 12 hours, I had an extreme case of the chills accompanied by nausea, body aches, and lethargy. These symptoms lasted approximately 48 hours.
4AUG97 t106 also vomiting approx 4hr p/vax given APAP alternating w/motrin & tepid bath per ER;5AUG97 f/u AM t102.9 fluctuating temp 5AUG & 6AUG started URi 7AUG97;
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age. On an unknown date the patient was vaccinated with ROTATEQ vial, lot# H17671, expiration date 25-MAR-2014 (dose and route were not reported) that was exposed to 12C for 173.5 hours, which was an excursion that was not supported by in-house stability data. No adverse effect reported. No concomitant medications were reported. This is one of several reports received from same source. Additional information has been requested.
Left sided (facial, arm, leg) parasthesias; Left arm erythema; dysphagia
Symptoms started ~8 hours after injection: muscle aches in shoulders, torso, hips; frontal headache; headache behind eyes; substantial burning or needle-like skin sensation in back, hips, and stomach; stabbing pain in right elbow joint; increased anxiety; general flush feeling. After12 hours: continued skin burning discomfort; extreme chills; difficulty sleeping; fatigue After 24 hours: most symptoms residing; slight headache After 48 hours: all symptoms gone
Increasing shortness of breath with exertion, chest fullness, dry cough, increased fatigue and aches.  Sx are intermittent since COVID vaccine booster on 12/07/21
body aches; muscle pain; joint pain; headache; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a male patient of an unspecified age received his first dose of bnt162b2 (BNT162B2 also reported as Covid-19 Vaccine, lot/batch number and expiry date were not reported), via an unspecified route of administration on 14Jan2021 at single dose, for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced body aches, muscle pain, joint pain and headache on Jan2021. The outcome of events was unknown.    Information on the lot/batch number has been requested.
mouth is very dry; vomiting profusely during the call; nauseous; muscle pain; body is shaking; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nauseous), MYALGIA (muscle pain), TREMOR (body is shaking), DRY MOUTH (mouth is very dry) and VOMITING (vomiting profusely during the call) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057G20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METOPROLOL, VITAMIN D3, TRIAMTERENE, AMLODIPINE BESILATE (SELODIPINE), BUPROPION and ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced NAUSEA (nauseous), MYALGIA (muscle pain) and TREMOR (body is shaking). On an unknown date, the patient experienced DRY MOUTH (mouth is very dry) and VOMITING (vomiting profusely during the call). The patient was treated with BISMUTH SUBSALICYLATE, CALCIUM CARBONATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE;CALCIUM CARBONATE]) for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, NAUSEA (nauseous), MYALGIA (muscle pain), TREMOR (body is shaking), DRY MOUTH (mouth is very dry) and VOMITING (vomiting profusely during the call) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications Metoprolol, Vitamin, triamterene, Felodipine, bupropion, Aspirin Patient had taken treatment medication OTC Pepto Bismol.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: NNI
THIS IS NOT AN ADVERSE EFFECT , WE USED THE MODERNA ONE DAY AFTER THE BEYOND USED DATE  , THE LOT NUMBER DID NOT EXPIRE , WE HAVE CALLED MODERNA, PATIENT HAVE NOT REPORTED ANY ADVERSE EFFETS
Patient came to pharmacy with red, inflamed, warm size of half dollar reaction at site of injection. She did not feel bad and did not have a fever.
The patient and 2 other siblings came in for a routine flu vaccination. I had all three flu vaccinations pulled up including 1 flu less than 3 for patient, and 2 flu over 3 for the two older siblings. Usually the youngest one goes first or last so I had them in order. One of the siblings was having a hard time cooperating for the vaccine. So, the patient went second. I accidently gave the patient, who is 20 months of age, a flu 3 and older shot. I recognized this right away and reported it to the patient's mom and my supervisor.
Within about a minute after the injection in my arm, I had trouble breathing and felt slightly woozy. I started to tell the pharmacist but it already seemed to be receding even as I stood up and walked around, so I decided to ride it out if I could. Shortly after, sharp pains shot through my lower back. This kept up for maybe 10 minutes but eventually stopped. I have never had an adverse reaction, or any reaction at all except some slight soreness in my arm, from a flu shot before.
I also received a tetanus shot.   I had difficulty breathing, shortness of breath, headache, body aches
On January 7, 2023 my son began to experience neck pain, thigh pain and pain in his knees to the point it?s painful and prevents him from walking properly.
Heart attack; This is a spontaneous report from a non-contactable consumer (patient). This 70-year-old female patient (not pregnant at time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose in right arm on an unspecified date for COVID-19 immunization. Medical history and concomitant medication were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Covid-19 test was negative. The patient had a heart attack four days after first vaccination. The adverse event result in emergency room/department or urgent care and received treatment. Seriousness criteria was caused/prolonged hospitalization for 4 days, not results in death, not life threatening, not disabling/incapacitating, not congenital anomaly/birth defect. The outcome of event was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
arm hurt, bone started popping, cold sweats, could not raise arm over head, deep aching pain in top of arm;
felt tired; chills; nausea; headache; i had a sore arm at the vaccination site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (i had a sore arm at the vaccination site), FATIGUE (felt tired), CHILLS (chills), NAUSEA (nausea) and HEADACHE (headache) 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 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jan-2021, the patient experienced VACCINATION SITE PAIN (i had a sore arm at the vaccination site). On 12-Jan-2021, the patient experienced FATIGUE (felt tired), CHILLS (chills), NAUSEA (nausea) and HEADACHE (headache). On 17-Jan-2021, VACCINATION SITE PAIN (i had a sore arm at the vaccination site), FATIGUE (felt tired), CHILLS (chills), NAUSEA (nausea) and HEADACHE (headache) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medication were not reported by the reporter. Treatment included aspirin.   Reporter did not allow further contact
Weakness; pain in legs; pain in legs - legs give out at any given moment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 2, SINGLE , lot number and expiration date not provided), for Covid-19 immunization; Covid-19 vaccine (DOSE 1, SINGLE , lot number and expiration date not provided), for Covid-19 immunization. The following information was reported: ASTHENIA (non-serious), outcome "not recovered", described as "Weakness"; PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "pain in legs"; MUSCULAR WEAKNESS (non-serious), outcome "not recovered", described as "pain in legs - legs give out at any given moment". The events "weakness", "pain in legs" and "pain in legs - legs give out at any given moment" required physician office visit. Therapeutic measures were taken as a result of asthenia, pain in extremity, muscular weakness.  Additional Information: Adverse event resulted in: Doctor or other healthcare professional office/clinic visit. It was unknown if the patient had taken the vaccine within 4 weeks. It was reported that the patient was undergoing physical therapy to try and fix it and so far not helping. It was unknown if the patient had covid before vaccination and it was unknown if the patient had tested for covid post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 03Dec2021 as dose 3 (booster), single (Lot number: 33130ba) at the age of 48 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 (PAXLOVID Treatment).
Severe thrombocytopenia (plts 3k/uL), oral mucosal bleeding, bruising
Redness and swelling at the site of tetanus/diphtheria injection administered 6/15/2012. Cephalexin prescribed, returned to hospital 6/21/2012 due to increase redness, swelling and tenderness at injection site.
Two days post vax the pt developed a rash or hives on leg. The rash progressed to whole body. Pt experienced a rash with a previous dose.
Information has been received from a nurse referring to a patient of unknown age and gender. Information about concurrent condition, drug reactions/allergies and medical history was not provided. On 14-SEP-2018, the patient received improperly stored (-14 Celsius (C) degree to -10 C degree for 5 hours; there was no previous temperature excursion) VARIVAX (lot # R017636, expiration date auto-generated as 20-JUN-2020, also reported as 30-JUN-2018; strength, dose, frequency and route were not reported) for prophylaxis and was also reconstituted with sterile diluent (MERCK) (lot # R001089, expiration date 18-SEP-2020; strength, dose, frequency and route were not reported). No adverse effect was reported. It was not because of a data logger. Sender's Comments: US-009507513-1810USA003203: US-009507513-1810USA011661.
One day post vax, four pts developed an injection site reaction characterized by pain and swelling.  Additional reports will be generated when identifying information is provided.
Arm pain after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain after vaccination) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K2JA) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Coronary disease.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced PAIN IN EXTREMITY (Arm pain after vaccination). In January 2021, PAIN IN EXTREMITY (Arm pain after vaccination) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported. No treatment information was reported.