chrisvoncsefalvay/vaers-outcomes huggingface dataset:
69 expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (69 expired doses administered). On 07-Jan-2022, EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Treatment medications were not reported.
Patient was administered vaccine with brother and mom present in the room by CMA. Vaccines was administered at 11:20 and patient and sibling was observed for 5 minutes following older siblings administration of Gardasil 9-writer confirmed with both moth and siblings that they were not feeling any dizziness or lightheadedness and patients were allowed to leave. At 11:35am writer heard mom exclaim from the waiting room, "oh my god, are you okay?" writer then got up on and saw patient beign cradeled in moms arms-ath which point PCP instructed mom to pick patient up and bring him to the room so that legs can be elevated and patient can be given ice pack. patient was place in the room with legs
Expired Bexsero was administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB58AA, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 5th October 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 5th October 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 10-OCT-2022 Reporter's Comment: The reporter was a medical assistant. The reporter reported that the patient received expired Bexsero vaccine. The reporter did consent to follow up. Additional supportive information: The patient received a Bexsero which was already expired, which led to expired vaccine used.  This case has been linked to the US2022144895 case reported by the same reporter.; Sender's Comments:  US-GSK-US2022144895:same reporter
sore arm; tiny bump at injection site; dizziness; feels warm; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), VACCINATION SITE MASS (tiny bump at injection site), DIZZINESS (dizziness), FEELING HOT (feels warm) and FATIGUE (fatigue) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), VACCINATION SITE MASS (tiny bump at injection site), DIZZINESS (dizziness), FEELING HOT (feels warm) and FATIGUE (fatigue). At the time of the report, PAIN IN EXTREMITY (sore arm), VACCINATION SITE MASS (tiny bump at injection site), DIZZINESS (dizziness), FEELING HOT (feels warm) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment medications were not provided by the reporter   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Non significant follow up appended On 21-Jul-2021: NNI,Patient declined for follow up
Sore arm; This is a spontaneous report from a contactable consumer, the patient. A 73-years-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot Number: unknown) as a single dose for COVID-19 immunisation. The patient's medical history was none. Concomitant medications were not reported. The patient experienced sore arm a few hours after the first dose on an unspecified date. The outcome of event, sore arm, was unknown.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021102574 same patient, different dose/AE (second dose)
Patient was given her 2 HPV vaccine at 10:15. She was walking out in the lobby by the Clinic front desk. Patient told her mom she did not feel well and had a syncopal episode. She fell and hit her head on the floor. She came to quickly. Ice applied to head taken to exam room via wheelchair.  Provider examined patient- no signs of concussion. Patient felt better and was discharged to home at 10:52.
Left shoulder tendonitis began 1 wk after flu vaccine on 10-6-16. Chiropractor visit 10-14-16. PCP visit 10-28-16. Orthopedic visit 11-1-16. Physical Therapy 11-8-16.
Information has been received from a consumer (the mother of the patient) referring to a female patient of unknown age. Information about concomitant medications, pertinent medical history and drug reactions/allergies was not reported. On an unknown date, the patient was vaccinated with M-M-R II, RECOMBIVAX HB, ROTATEQ, Hib conj vaccine (unspecified carrier) (manufacturer unknown), PNEUMOVAX 23, VARIVAX and VAQTA according to CDC guidelines for prophylaxis. On an unknown date, the patient experienced a "side effect" to these vaccines (Merck could not be ruled out). The outcome of "side effect" was unknown. Information about treatment given for the event, lab diagnostics/studies and medical attention was not provided. The causality assessment between "side effect" with these vaccines was related.
Severe hives 45 minutes after shot given: arm was triple the size for 4-5 days, red, hot and very tender.
Information has been received on 04-JAN-2018 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In January 2017, the patient's healthcare provider at a physician's office administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. In January 2017, the patient was treated by the patient's healthcare provider at a physician's office for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is not recovered. The causality of the events is related. Additional information has been requested.
Erection; Low energy; This spontaneous case was reported by a consumer and describes the occurrence of SPONTANEOUS PENILE ERECTION (Erection) and ASTHENIA (Low energy) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced SPONTANEOUS PENILE ERECTION (Erection) and ASTHENIA (Low energy). On 05-Mar-2021, ASTHENIA (Low energy) had resolved. On 06-Mar-2021, SPONTANEOUS PENILE ERECTION (Erection) 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.
Fever 103F, chills and fatigue; onset 2-3 months, post vax. Duration 24-48 hours.
Patient was mistakenly give 0.25ml dose instead of the indicated 0.5ml dose. Patient returned to the pharmacy the next day to receive the remainder of the dose.
This spontaneous report as received from a pharmacist refers to a 57 year old female patient with no pertinent medical history and no drug reactions or allergies. On 13-NOV-2013 the patient was vaccinated with ZOSTAVAX 0.65 ml injection, subcutaneously (lot number # J006827, expiration date 14-SEP-2013). On 16-NOV-2013 the patient experienced visual disturbances and headaches that come and go. The patient reported that she had a hair-like object in the front of her eye, that was blocking her vision and that could not be wiped away. No treatment was given and no lab diagnostics studies were performed. The outcome of visual disturbances and headaches was reported as not recovered/not resolved. The relatedness between vaccination with ZOSTAVAX and visual disturbances and headaches was not reported. Additional information has been requested.
Influenza vaccine given 10-24-16 and left arm major swelling began 10-25-16 to ER 10-258-16 and saw Dr and said allergic reaction and no treatment then more swelling and redness 10-26-16 No pain, swelling down to forearm.
Pain at the injection site which keeps the patient awake at night; Pain at the injection site which keeps the patient awake at night; injection site pain was unrelated to patient's medical history and was straight muscle or bone issue and was isolated; injection site pain was unrelated to patient's medical history and was straight muscle or bone issue and was isolated; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 67 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in left arm, administration date 13Feb2021 10:00 (Lot number: EL3248) at the age of 67 years as dose 1, single and administered in left arm, administration date 06Mar2021 13:00 (Lot number: EN6199) at the age of 67 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetic", start date: 2001 (ongoing); "Congestive Heart Failure", start date: 2020 (ongoing). The patient took concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 13Feb2021, outcome "not recovered", POOR QUALITY SLEEP (non-serious) with onset Feb2021, outcome "not recovered" and all described as "Pain at the injection site which keeps the patient awake at night"; MUSCLE DISORDER (non-serious), BONE DISORDER (non-serious) all with onset Feb2021, outcome "not recovered" and all described as "injection site pain was unrelated to patient's medical history and was straight muscle or bone issue and was isolated". Therapeutic measures were taken as a result of vaccination site pain. Additional information: Unspecified treatment included something to rub on the vaccination site (as reported). The patient also received topical lidocaine patches, diclofenac sodium topical gel, and applied heat and cold on the site. The patient was also taking unspecified diabetes medication.  No follow-up attempts are possible. No further information is expected.
pt recvd vax & started crying 3P-cont til 9P w/o stopping; had been given APAP @time of immun q 4 hrs; afebrile w/no redness or swelling or tenderness @ inject site;
Painful, swollen lymph nodes in the armpit of the arm where I received my vaccination. Lasted for 6 days.
On the evening the dose was received (4/7/21) patient noticed rash and swelling.  Patient states redness was approximately 2 inches around the injection site, patient states it is warm/hot to the touch and swollen. As of today 4/13/21 level of redness, swelling have been stable and she called us as she expected symptoms would have resolved by now and because she has an underlying swelling condition that may confound level of swelling.  Patient referred to contact primary care provider or seek treatment at walk-in clinic/urgent care for evaluation. Presently unaware if patient has followed recommendation and sought evaluation by healthcare provider, but expect that provider to complete their own VAERs or the patient will follow up with the pharmacy and we will submit a new form with those dates and outcomes.
Swelling and soreness at site but it radiates up the left side ofmy neck and my left cheek is warm which is unlike the reaction to the first shop.
Tiredness; Soreness; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season (intramuscular). On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced tiredness and pain. On an unknown date, the outcome of the tiredness and pain were unknown.   It was unknown if the reporter considered the tiredness and pain to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were reported as follows: The age at vaccination was not reported. The patient reported the case for herself. The patient experienced tiredness and soreness after receiving the flu vaccine.  No additional information was available. The reporter did not consent to follow-up.
Pulmonary embolism, joint pain, all over nerve pain, chest pain, muscle spasms
Pt recvd 3 Hepatitis-B vax 26JUL89, 31AUG89, 25JAN90 & a 4th dose of vax 5SEP90; following these titer was neg;
On 12/28/00 at 4:30AM to 12/30/00 9:00am the pt experienced a fever of up to 104-105 with Tylenol every 4 hours. The fever would drop to 102 but then spike back up to 104/105. On 12/30/00 at 9:00 am to 12/30/00 8:00pm the pt experienced a fever of 102, treated with Tylenol. On 12/29/00 the skin around the eyes were red and eyes were watery. On 12/30/00 at 6:00pm the pt had a head to toe rash - red dots, some raised and most hot. No discomfort was noted with rash.
Tingling sensation on the left lower leg; Burning sensation on the left lower leg; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534) via an unspecified route of administration on 22Mar2021 at 14:45 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none also the patient did not have any allergies to medications, food, or other products. Concomitant medications included vitamin (MANUFACTURER UNKNOWN) one a day from an unknown date. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 24Mar2021 at 01:30, the patient experienced intermittent tingling and burning sensation on the left lower leg (outside of calf). The patient stated that it started approximately 36 hours after the shot. The tingling was intense enough to wake him up from sleep. This lasted about 36 hours. The tingling frequency and intensity slowly decreased over the 36 hour time period.  The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the adverse events. The clinical outcome of the events tingling and burning sensation on the left lower leg were resolving at the time of the report.   No follow-up attempts are needed. No further information is expected.
Approximately 12 hours after receiving the moderna Covid vaccine I've had a low grade fever and chills.  Three days after the shot, I experienced the worst headache of my life.  I received my shot 6 days ago and I still feel very "hot"/low grade fever and experiencing flushing of the face.  The symptoms haven't felt serious but I'm hearing approximately 60% of individuals I speak with are experiencing the same or worse symptoms.  I worry that individuals won't want to receive their 2nd shot due to the reported side effects.  I believe more awareness should be communicated to the general public, so they aren't caught off guard.   I had a covid test conducted on Friday (negative) and will get another one this week to be certain I do not have covid.
Starting within an hour of vaccination, I had major soreness in upper arm and had difficulty lifting arm.  This is normal for me for the 2 days after vaccination but my pain is still consistent on 10/28 - 18 days after the injection.  Pain moving, pushing, pulling, lifting, twisting across upper arm directly below tip of shoulder bone that affects everything I do.  I tried taking the NP recommended does of 600mg 3x a day of ibuprofen for 5 days and did not feel any change besides a slight dulling of the pain.  Today, 10/28, I began the NP prescribed Prednisone which I will take for 5 days.  I had no pain before this injection.
Her outbreak of what she had going on was right after her first Pfizer COVID-19 vaccination...she has been diagnosed with Lichen planus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient received BNT162b2 (BNT162B2), on 27Mar2021 as dose 1, single (Lot number: EN6204) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: LICHEN PLANUS (non-serious) with onset May2021, outcome "not recovered", described as "Her outbreak of what she had going on was right after her first Pfizer COVID-19 vaccination...she has been diagnosed with Lichen planus".  Additional information: Has come to her attention when she had the Pfizer vaccination for COVID in 2021, she had some effects with this. She did not think anything about it. Went to her dermatologist with the issue. Now with all her research, she was going back to her dermatologist. Her outbreak of what she had going on was right after her first Pfizer COVID-19 vaccination and then continued to get worse after the second vaccination. The ailment was caused by Pfizer. Clarified she has been diagnosed with Lichen planus, a rash type of situation and this all came about. She had Lichen planus before but not in this area and not to the extent of the breakout.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300046916 same product, patient, different AEs, different dose;
Starting one week after receiving the vaccine, I started feeling dizzy, heart palpitations, a racing heartbeat and anxious almost daily. It got to the point where it made it hard to function. One day, I woke up and got out of bed but fell to the floor because the room was spinning. I took an OTC anti-nausea medicine and got back into bed. However, after some time, I did not get better and also started sweating, feeling like my hands and legs were numb and was vomitting. So, I called 911 and was sent to the ER. They checked my BP which was sky high, and did an MRI and EKG, which were normal. I spent 4 days in the hospital and was released due to not getting better. I was told it was likely an inner ear issue and was referred to an ENT. After numerous tests, they determined it was not an inner ear issue. At this point, I am unsure what is causing my symptoms. While they have improved, they are not 100% better. I am unable to lie flat (I must lay with some slight elevation) and I am unable to look in any direction with only my head (it will cause the room to spin). Also, if I walk anywhere I try to hold onto things for safety and avoid driving unless necessary.
Symptoms: fever, chills, body aches, head ache, malaise. Treated with ibuprofen 200mg and  acetaminophen 300mg. First broke fever 38 hrs after vaccination. Mild fever returned within 8 hrs but was managed with acetaminophen.
On day 8 after receiving my vaccine, Moderna, below injection site a red, raised area & itching. On day 14 still having a red spot around 3" in size, with some itching.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: If vaccine received was reported as Yes. No other medication in 2 weeks reported and no known allergies was reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt states she was fine until 11:30 am when she arrived home then arm pain began then she started shaking from head to toe "violently-like you see in a horror movie",  then she was sick to her stomach so she proceeded to the bathroom where she fell head first into the bathroom (1st fall), then she got up, turned towards the toilet and fell again where she remained for about 30 minutes.  She crawled to her bedroom and she checked her temperature which was 101 degrees F which lowered to 99 F over the course a the next few days.  She cooled herself with ice packs but she remained unsteady and could not walk right for nearly a week.  The bruise and arm pain persisted for about 3 weeks,  Patient reports that she still experiences unsteadiness that persists nearly 1 month post vaccination.
23JUN observed knot rt leg upper part; called MD said to observe & put warm compresses; 30JUN92 knot was bigger & tight & tender to touch & began draining; 30JUN92 told to call MD;
Area where patient had a needle stick for blood stick became flared and had blisters around it.