chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Administer expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) in a 60-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine). On 08-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product information was not provided. Reporter stated that no treatment was given to patients.  Reporter also stated that the vaccines were stored in freezer and they took out one to two vials and placed in fridge each day as needed.
Vaccine administered 7 days ago. Redness and swelling to top half of arm. After 7 day top half of arm was clear and bottom of half arm above elbow is red and swollen and warm to this touch. Doctor visit on May 3, 2016.
Within 1 week, the following experienced severely inflamed: Colitis (Have had diarrahea for 5 weeks) Lower back (Received steroid shots) Prostrate (Was put on medication to reduce leaking and pain) Right risk (Received steroid shot)
This spontaneous report was received from a Nurse Practitioner referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.   On 08-NOV-2016, the patient received, in their immunization series, an unspecified dose of VARIVAX Lot # M006157 and expiration date: 05-FEB-2018 (dose and route of administration were not reported) for prophylaxis  that was improperly stored. It was reported a temperature of 8° Fahrenheit during a time frame of 1 hour. There was a previous temperature excursions of 8.6° Fahrenheit and 41° Fahrenheit for 1 hour 30 minutes and 17 hours and 50 minutes, respectively. The call was not because of a data logger. No adverse effects were reported.  There was no product quality complaint involved. This is one of several reports received by the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA009077: US-009507513-1702USA009079:
This spontaneous report was received from a medical assistant and refers to a 1-month-old patient. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 18-JUN-2018, the patient was vaccinated with a 0.5 ml dose of VAQTA intramuscular injection, lot # N026997 with expiration date on 10-NOV-2018 in error instead of an unspecified hepatitis b vaccine (manufacturer unknown). The reporter confirmed there was no product confusion. No adverse effects were reported.
Nausea, vomiting x 3, and hyperglycemia (BG: 350s) 30 to 60 minutes following 0.3 mL IM injection of Pfizer-BioNTech COVID-19 vaccine in the left deltoid.
This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (nosebleeds), VACCINATION SITE PRURITUS (itchy rash at the injection site) and VACCINATION SITE ERYTHEMA (itch rashy) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (itchy rash at the injection site) and VACCINATION SITE ERYTHEMA (itch rashy). On an unknown date, the patient experienced EPISTAXIS (nosebleeds). At the time of the report, EPISTAXIS (nosebleeds) outcome was unknown and VACCINATION SITE PRURITUS (itchy rash at the injection site) and VACCINATION SITE ERYTHEMA (itch rashy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information was not provided by the reporter.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-May-2021: Event information updated,
his reflux was aggravated; his reflux was aggravated; had regurgitation in the back of his throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 2-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "reflux" (not ongoing), notes: He is a "reflux infant" so has a history of reflux but has resolved. The patient's concomitant medications were not reported. The following information was reported: GASTROOESOPHAGEAL REFLUX DISEASE (non-serious), DISEASE RECURRENCE (non-serious), outcome "recovered" and all described as "his reflux was aggravated"; REGURGITATION (non-serious), outcome "unknown", described as "had regurgitation in the back of his throat". Additional information: the mother of patient reported that her son is a "reflux infant" so has a history of reflux but has resolved. She reported that every time he got the vaccine (has received 3 doses), it aggravated his reflux or it started acting up again. On Monday, 06Mar2023, he received his Pfizer Covid 19 vaccine bivalent booster for 6 months to 4 years old, and she noticed that night his reflux was aggravated and had regurgitation in the back of his throat that night and has been occurring intermittently since then. This same thing happened with his first two doses in his primary series.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300102877 Same reporter, same patient, same event, different shot;US-PFIZER INC-202300102439 Same reporter, same patient, different shot/event;
DRY COUGH, CHEST CONGESTION. O2, RX HUMIDIFIER, ALBUTEROL INHALER. UNCONTROLABLE SHAKING. FEVER 102.
Itchy skin that started yesterday after receiving 2nd dose on 04/17/2021. Then started having rash appear on my bilateral upper extremities on my forearms and hands. Skin: Positive for rash. APRN provided steroid shot while in clinic, recommended take OTC Zyrtec twice a day for the next 2 days then take daily, recommended over-the-counter Eucerin antiitch lotion twice daily;   If not improving in signs and next 24 to 48 hours or if worsening return to clinic; Has any symptoms of feeling like cannot breathe, throat is closing, chest pain, etc, Recommend call 911;
Rash developing 2 days after vaccines. Starting on soles spreading to legs, buttocks and arms. No fevers, cough or congestion. Rash consistent with hand, foot and mouth.
Arm starting hurting several hours after shot. By night she was in tears and couldn't move arm. Next day still couldn't move arm and went to urgent care. On 10/1 area still sore and had limited mobility.
arm and leg bruising with light contact against objects, irregular heart beat, occasional low pulse ( mid 40s), difficulty breathing with exercise especially during times of low heart rate, raspy voice, persistent cough for two months, cold sensitivity in all teeth
He mentioned that he was in respirator for 3 weeks due to pneumonia; This is a spontaneous report received from a non-contactable consumer (patient) via a Pfizer-sponsored program Support. A male patient of an unspecified age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: Unknown), via an unspecified route of administration on an unspecified date as dose 1, single and a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: Unknown), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. Medical history included covid from Nov2020 to an unknown date, and had been in the hospital for 2 or 3 months. Caller said that he was a Covid survivor in November before the vaccine. The patient concomitant medications were not reported. He mentioned that he was in respirator for 3 weeks due to pneumonia on unknown date. The event was assessed as serious (medically significant). Caller was thankful about the vaccine and he was willing to take the booster shot. Call got disconnected before clarifying to the caller if he was tested positive before or after taking the vaccine. The outcome of the event was reported as unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Patient's report: "Started to notice swelling in my right arm pit on 1/12/2021 and tenderness in my neck also on 1/12/2021 I had the second shot on 1/11/2021 at 12pm"
The continuing conditions are inability to be upright, and cognitive issue and nausea, drops in blood pressure and also had constant migraine, which still continues. I had an MRI on May 21, 2022. Orthostatic tachycardiac, new cognitive conditions and a lot of weakness, and fatigue. Although I can sit upright a year later, I need to have my legs upright. I am now a full-time wheelchair user. Started optic neuritis approximately on August 13, 2022 and I had lost my vision for about 2 months, which has mostly recovered but not fully.
Information has been received from a health professional concerning a male child around 7 years old who in 2000 was vaccinated with a dose of varicella virus vaccine live.  In November 2005, the patient experienced a mild case of chickenpox.  The patient had lesions on his trunk and back.  Subsequently, the patient recovered.  Unspecified medical attention was sought.  No product quality complaint was involved.  No other information was provided.  Additional information has been requested.
This spontaneous report as received from a physician refers to a 65 year old female patient with none pertinent medical history and no comorbidities. On an unknown date the patient was vaccinated with a dose of PNEUMOVAX 23 0.5 ml intramuscularly (lot number and expiration date not provided). No concomitant medication was reported. On an unknown date the patient experienced erythema, fever, swelling, pain and severe arm swelling within 24 hours of receiving PNEUMOVAX 23. The patient sought medical attention - was seen in the emergency department but was not admitted to the hospital. The patient was diagnosed with cellulitis. The patient was prescribed vancomycin (manufacturer unknown) intravenously (dosage unspecified). The outcome of the events was reported as recovered. The relatedness between vaccination and PNEUMOVAX 23 and events was not reported. This is one of three reports from the same source (#1401USA0030078, #1401USA001748). Additional information has been requested.
redness about 5 inches by 5 inches; This spontaneous case was reported by a nurse and describes the occurrence of   in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        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.   Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Hives in early morning of 11/20/21 followed by dizziness, shakiness and serious nervous agitation by late morning.  Hives did not worsen but did not start to improve for 3 more days.  Very fatigued for approximately 10 days following vaccination booster on 11/15/21.
arm of injection warm to touch; itchy rash of 5-6 inches high to 3-4 inches wide; arm of injection swollen; arm of injection slightly sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (arm of injection warm to touch), VACCINATION SITE RASH (itchy rash of 5-6 inches high to 3-4 inches wide), VACCINATION SITE SWELLING (arm of injection swollen) and MYALGIA (arm of injection slightly sore) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Concomitant products included BLOOD PRESSURE MEDICINE, MELOXICAM, VITAMINS NOS, SUPPLEMENTS and ALUMINIUM SULFATE, CALCIUM ACETATE (ASTRINGENT SOLUTION) for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (arm of injection warm to touch), VACCINATION SITE RASH (itchy rash of 5-6 inches high to 3-4 inches wide), VACCINATION SITE SWELLING (arm of injection swollen) and MYALGIA (arm of injection slightly sore). At the time of the report, VACCINATION SITE WARMTH (arm of injection warm to touch), VACCINATION SITE RASH (itchy rash of 5-6 inches high to 3-4 inches wide), VACCINATION SITE SWELLING (arm of injection swollen) and MYALGIA (arm of injection slightly sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment for the event included asper cream (OTC) that helps with the itch.
Pt. states that after receiving the 2nd dose of Phizer 07/22/2021, started experiencing symptoms 07/23/2021 of extreme back pain throughout the lower and upper back. Urgent Care visit 07/24/2021 no testing issued. Prednisone and Toradol prescribed. Urgent Care visit 08/05/2021 set to be off work due to pain ailment. Symptoms still presistant.
Exactly 2 weeks following administration of my 2nd COVID-19 vaccination, I started to notice red bumps appearing on my lower back, and hip area on my right side.  I also had the same bumps on one of my knees.  They didn't itch, and when I scratched them open they were fluid filled, but didn't show signs of healing.  Two days later, thanks to my training as a pharmacist, I realized that the bumps were wrapping around my body following a dermatome.  I saw my doctor that Friday afternoon (2 days after the bumps first appeared), and he confirmed Shingles and started me on Valtrex.  By that weekend the bumps started to itch, and when scratched caused a painful burning sensation.  The bumps then took several weeks to clear up and heal completely.  It was a mild case, and I am thankful that I caught it early.  I haven't gotten a booster dose, due to this reaction.
Aprox 1 min after receiving injection patient felt short of breath. Patient was immediatly assesed by a Nurse practitioner who gave her a pediatric dose of Benedryl and subsequently given EPI via EPI pen-Pediatric dose. 911 called and transported to the hospital via EMS.
Severe headache soon after administration (~30-60mins) lasting 18 hours. HA did resolve and has not returned.Denies any other symptoms or reaction.
The day after my second shot, the injection site turned bright red and itchy. The next day a rash appeared in my arm and wrapped around it. It reminds me of a jellyfish sting. I?ve been taking Benadryl at night and spraying with a topical Benadryl.  It still itches/stings today but seems to be getting better.
Pregnant EDD: 12/19/2021 Dx: DIC complications after miscarriage
10 minutes post-vaccination, lips started going numb; 12 minutes post-vac fullness feeling in throat; 15-20 min post vac red, flushed, sweaty
fever, nausea, swollen face, arm swollen, swollen throat, took Benadryl and ibuprofen. last thing we heard from her she was doing better, but was still feeling ill.
VIAL WAS PUNCTURED AND LEFT OVERNIGHT (OVER 6 HOURS); This spontaneous report received from a pharmacist concerned a 57 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 211A21A, and expiry: 14-DEC-2021) dose was not reported, administered on 25-OCT-2021 11:40 for prophylactic vaccination. No concomitant medications were reported. On 25-OCT-2021, the patient experienced vial was punctured and left overnight (over 6 hours). The action taken with covid-19 vaccine  was not applicable. The outcome of vial was punctured and left overnight (over 6 hours) was not reported. This report was non-serious. This case, from the same reporter is linked to 20211050252.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE HYPOXEMIC RESPIRATORY FAILURE 5/8/2022 &  5/24/2022  -- RECURRENCE OF SAME SYMPTOMS
63 y.o. female patient with PMHx of COPD s/p bilateral lung transplant (CMV D+/R+, EBV D+/R+, Toxo D-/R-) from an increased risk donor on 6/14/18 who was HCV NAT+/Ab+ as well as HBcAb+ and history of acute transplant rejection who presented to ED for dyspnea on exertion for two days. She was found to have had exposure to close contact with Covid 19 infection. She was previously vaccinated for COVID; admitted 8/1/2021 with confirmed COVID-19. Respiratory status has been worsening, requiring higher oxygen suppor, thus she was transferred to the MICU. At a local hospital, she was started on HFNC and then intubated for increasing/worsening hypoxia. ICU course complicated by need for ECMO cannulation with ARDS, sepsis from E.faecalis UTI and strep pneumoniae PNA ISO aspergillus colonization, and acute bilateral lung transplant rejection. Overall burden of lung injury felt to be not survivable, so her family made the decision for CMO on 9/12/21. VV ECMO support discontinued at 12:35 PM on 9/12/2021 and time of death was 1:05 PM on 9/12/2021.
Information has been received concerning a patient who was vaccinated with Zostavax.  Subsequently the patient experienced a red rash at the injection site.  This is one of several reports from the same source.  No further information is available.
Nausea; high fever 101f.; Pain throughout body; 48 year's old patient received shingles vaccine; This non-serious case was reported by a consumer and described the occurrence of nausea in a 48-year-old female patient who received Herpes zoster (Shingles vaccine) (batch number 3N743, expiry date 20-AUG-2024) for prophylaxis.   On 14-JUL-2023, the patient received Shingles vaccine. On 14-JUL-2023, less than a day after receiving Shingles vaccine, the patient experienced nausea (Verbatim: Nausea), fever (Verbatim: high fever 101f.), general body pain (Verbatim: Pain throughout body) and inappropriate age at vaccine administration (Verbatim: 48 year's old patient received shingles vaccine). The outcome of the nausea, fever and general body pain were not resolved and the outcome of the inappropriate age at vaccine administration was unknown.   It was unknown if the reporter considered the nausea, fever and general body pain to be related to Shingles vaccine.     It was unknown if the company considered the nausea, fever and general body pain to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 15-JUL-2023 The patient self-reported this case. The symptoms were not treated. On 15 July 2023 the outcome of events was reported as not recovered. The reporter consent to follow up by email. The patient received Shingles vaccine before recommended age, which led to inappropriate age at vaccine administration.
Right after instruction, headache behind eyes, pain up side of neck, pain under armpit (all on side of injection). Continued pain at infection site after two days. At Day two I developed a round rash the size of a quarter and it is hot to the touch.
6/23/22 Received vaccine 6/24/22 Seen by NP with c/o not feeling well. Fatigue and not eating but drinking appropriately. 6/27/22 Found unresponsive in room.
Mild erythema and edema from the injection site to 2 inches above the elbow.
DEPRESSION; COULD NOT EAT; LOSS OF WEIGHT; BRAIN IMBALANCE; ANXIETY; TREMBLING; STUTTERING; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was healthy as a horse. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 23-JUL-2021 for covid-19 prophylaxis. No concomitant medications were reported. On JUL-2021, the patient experienced headache, and nausea. On an unspecified date, the patient experienced depression, could not eat, loss of weight, brain imbalance, anxiety, trembling, and stuttering. Laboratory data (dates unspecified) included: Lab test vaccine had triggered something in her brain and caused an imbalance in her brain. Treatment medications (dates unspecified) included: sertraline, mirtazapine, clozapine, and aripiprazole. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from depression, anxiety, trembling, and stuttering, and the outcome of headache, nausea, could not eat, loss of weight and brain imbalance was not reported. This report was non-serious.
Swollen, red band around upper arm , below injection site on day 4 after second dose.  Puffy, not, very pink with a clear, distinct line.  Area was about three inches in height and circumferenced the arm with swelling and arecwas hot compared to nearby skin
Extreme soreness at the injection site, but no redness, muscle weakness, dizzyness, joint pain, muscle aches, lowgrade fever (+ 2degrees), severe headache, and overwhelming exhaustion - difficulty walking. Lasted approximately 18 hours.  Peaked 4 hours after onset of symptoms. All symptoms gone by next evening except lingering fatigue and headache, and soreness at the injection site.
We were out of town and drove home on last Saturday. Prior to intermingling with family, we decided to test that Sunday and we both tested positive. I was tired but I thought it was from the traveling or not sleeping well. I still did not develop more severe symptoms. I felt tired and like I had pressure on my ears. I contacted the doctor on Monday morning, and he prescribed PAXLOVID. I'm halfway through the medication and the symptoms are subsiding but the ear soreness is still there.
ADVERSE REACTION; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unk) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the subject experienced adverse reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of adverse reaction was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious
CT of the chest revealed significant bilateral PE with possible heart strain. Was given TPA. Monitoring after receiving after TPA and improved