chrisvoncsefalvay/vaers-outcomes huggingface dataset:
not immunocompromised, but got full dose for booster; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (not immunocompromised, but got full dose for booster) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939903, 031L20A and 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included Heart disease, unspecified (Heart issues).   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL OVERDOSE (not immunocompromised, but got full dose for booster). On 30-Nov-2021, ACCIDENTAL OVERDOSE (not immunocompromised, but got full dose for booster) had resolved.            No concomitant medication details was reported. No treatment medication details was reported.   This case was linked to MOD-2021-403031 (Patient Link).; Sender's Comments: Case routed out of MR workflow as medical review is not required per new CMOP process for non serious cases which are not AESI and LOE
Reported her daughter had a tender shoulder after her first COVID-19 Vaccine dose; This is a spontaneous report from a contactable consumer or other non-healthcare professional (parent). A 35-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date in Jan2021 (age at the time of vaccination was 35 years) as DOSE 1, SINGLE for covid-19 immunization at Clinic. The patient medical history, concomitant medications and other products were not reported. On an unspecified date in 2021, the reporter(s) her daughter had a tender shoulder after her first covid-19 vaccine dose. The reporter clarified her daughter's shoulder was tender enough to wake her up at night was she laid on her shoulder. It was reported her daughter got her COVID-19 Vaccine from the Health Department and stated that her daughter was a clinical psychologist. She said her daughter received her first COVID-19 Vaccine dose within the first 3 weeks of giving the COVID-19 Vaccine out. It was reported her daughter's shoulder tenderness lessened over the following days, and in 2-3 days her daughter's tender shoulder was gone. It was reported that as maybe her daughter took the same brand Ibuprofen she used (Equiline Brand) because she had seen a bottle of Equiline Brand Ibuprofen at her daughter's house. The reporter said she did not have the Ibuprofen NDC, Lot, and Expiration Date. The outcome of the event was recovered on an unspecified date in 2021.  No follow-up attempts are possible. Information on lot number, batch number could not be obtained.
Subsequent to receiving vax, the pt experienced a local reaction characterized by a 3 cm area of redness. Additional information received reports that the pt developed the local reaction on his left arm. Reportedly the pt recovered from this experience.
Developed rash on back + buttocks + breast the day after injection per patient.  Pt continues to be treated with magic mouth wash for sores she developed in mouth.  She reports she developed in mouth.  She reports she developed Thrush the day after as well.  but they continued to worsen.
This spontaneous report was received from an office manager referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not provided. On an unknown date the patients were vaccinated with GARDASIL 9 lot # R004689 and expiration date 29-NOV-2020 for prophylaxis (dose, frequency and route were not provided). Other suspect therapies included ROTATEQ lot# R002516 and expiration date 13-SEP-2019 for prophylaxis (dose, frequency and route were not provided). No adverse effects were reported. Digital data logger registered a temperature excursion between 0°C to l°C (0.2 C) for 86 hours. There were no previous temperature excursions registered. This case was determined to be non-valid as there was no patient identifier.
This is a spontaneous report from a contactable consumer (patient). A 72-year-old male consumer received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number: EL3249, expiry date unknown) via an unspecified route of administration on the left arm on 15Jan2021, 11:30AM at a single dose for COVID-19 immunization. The patient's medical history included being overweight. The patient had no known allergies to medications, food, or other products. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 15Jan2021 22:00, the patient experienced injection spot was a little sore, was very tired that night, and had some chills. No treatment was received in response to the events. Outcome of the events at the time of last observation was recovered. The events were considered non-serious.
After patient was given her first Pfizer vaccination, she returned to the pharmacy within about 5-10 minutes with a violent and persistent cough. She was asked if she could make her way to the immunization booth for water and evaluation and she did so urgently. While staff retrieved water for the patient, she informed the pharmacist that her chest was tightening and that she was having trouble breathing. Patient had discoloration in face, panicked expression, and was grabbing at her throat and upper chest. At that point, the pharmacist administered an Epi-pen into her right thigh and sat beside the patient for observation. The patient's breathing began to improve and the pharmacist recommended that the patient allow for her to call for emergency services. The patient declined stating that she would have her companion take her if she felt the chest tightening return. Store management came to get a statement from the patient and within about 10 minutes from first Epi-pen administration the patient informed the pharmacist and managerial staff member that the Epi-pen was wearing off and that she wished for a second dose, which was then administered. Patient agreed that with the second dose given she should report to ER and continued to state that she would have her driver take her if she wished. She was adamant that she did not want 911 called. The following day, on 7/10/22 the pharmacist called to  verify that the patient had recovered. The patient reported a night of coughing and some mild chest tightness but that she did not report to the ER or any other facility. She also reported feeling  much improved on 7/10/22.
fever,nausea,headache. PT states getting the J/J vaccine this am 1000 with shortness of breathe, nausea, and headache starting around 13/1400. PT states taking 500mg tylenol around 1.5 hours ago. DATA: 23-year-old male presents with constitutional symptoms after COVID vaccine reaction.. Stable on arrival, mildly febrile with moderate tachycardia and otherwise reassuring vitals.  Patient well-appearing on exam with no productive cough, hypoxia, abnormal lung sounds, or respiratory distress to suggest pneumonia. No urinary symptoms or abdominal pain to suggest UTI or other acute intraabdominal process. No AMS, neuro symptoms, meningismus, or rash to suggest meningitis/encephalitis. Non-toxic appearance; low concern for DATA: Med/Allg: denies PMH/PSH: denies  ROS HEENT: no eye pain, no sore throat, no ear pain CV: no chest pain, no palpitations Pulm: no shortness of breath, no cough Abd: no abdominal pain, no N/V/D MSK: no joint pain, no joint swelling, no back pain  PE Gen: A&Ox4, NAD, non-toxic appearing HEENT: no pharyngitis, no AOM/OE, no PTA/RPA/Ludwig's, no cervical adenopathy CV: S1/S2 RRR without MRG, cap refill <2 seconds all extr Pulm: CTA all fields, no dyspnea on exam Abd: no focal Abd TTP, no peritoneal signs, no CVA tenderness MSK moving all extremities without limitation, no gross deformities, no joint swelling or tenderness Neuro: CN 2-12 and cerebellar grossly intact Skin: maculopapular lesions on Bilat lower legs c/w contact dermatitis.   Lab: none indicated  Rad: none indicated
At 7:30 am on 3/13/2021, I felt light a lightening bolt hit my head and lower back. Pain was excruciating for 6 hours. Pain subsided slightly. Used heating pad. Pain developed on fronts of thighs. Took ibuprofen at 9 pm. Pain in all places was almost gone when I went to bd at 11 pm. When I got up at 6 am, all pain was gone!
CHRONIC HYPOXEMIC RESPIRATORY FAILURE ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 11/8/2022 &  2/16/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Her arm to go sore; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Her arm to go sore) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (Her arm to go sore). At the time of the report, MYALGIA (Her arm to go sore) outcome was unknown.            Concomitant medications and event treatment information, if any, was not provided by the reporter.   This case was linked to MOD-2021-045657 (Patient Link).
Redness & swelling & itching to left upper arm. On 3/2/12 redness moved to lower inner arm & warm to touch, swelling & itching resolved 3/5/12.
22OCT96 pt awoke w/lt arm/shoulder pain;12:30 PM aching lt arm & head;felt lightheaded & about to pass-APAP relieved h/a & muscle ache;took Ibuprofen 22OCT96-23OCT96 not feel well that AM by afternoon achy in lt should & head & upper spine
No additional AE reported; improperly stored vaccines were administered.; This spontaneous report was received from a nurse concerning a 23-year-old female patient. The patient's medical history, concurrent conditions, and concomitant medications were not provided.   On 16-MAY-2022, there was a temperature excursion reported for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II), which was improperly stored at 13.8 Celcius degrees, for 7 hours and 30 minutes. There was no previous temperature excursion.  On 20-MAY-2022, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) subcutaneous injection,  lot # U007684, expiration date 09-MAR-2023 (strength, dose, route of administration, and anatomical location were not provided) administered for prophylaxis (product storage error). No additional adverse events were reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2205USA007635: US-009507513-2205USA007943:
Starting the evening of 1/3/22 my scalp was extremely itchy. After a shower, my scalp started burning and I developed a rash/hives on the back of my neck. In the morning, I had developed welts behind my ears and all over my inner thighs and groin area, on both legs. Since then, I've developed welts on both the left and right sides of my waist, behind my knees, in my armpit area, on the tops of my feet, inside my wrists and on my palms. The welts come and go. The itchiness and burning is unbearable. I also have been getting red splotches on my face that come and go.
1. Within a week of the shot random pains/ cramping on opposite side of body and mostly in right arm that went on for weeks after the shot. 2. Randomly unable to articulate word or phrases to the point I know it?s happening but takes a few seconds to stop and reset then I?m fine. Never happened before vaccination. Will follow up with doctor at next visit in October
cold sores; This spontaneous case was reported by a consumer and describes the occurrence of ORAL HERPES (cold sores) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 15-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 ORAL HERPES (cold sores). At the time of the report, ORAL HERPES (cold sores) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Doses administered past the published expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry date) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry date). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.  On 18-Oct-2021, the vial was removed from freezer at 8 AM.
Dose number: 3; Persistent eye twitch since booster shot; This is a spontaneous report from a non-contactable reporter (consumer or other non HCP). The reporter is the patient.  A 28-year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Lot number: 33313OBA) at the age of 28 years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: EW0165; Route of administration unspecified), for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: EW0179; Route of administration unspecified), for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Dose number: 3"; BLEPHAROSPASM (non-serious), outcome "unknown", described as "Persistent eye twitch since booster shot". Therapeutic measures were not taken as a result of blepharospasm.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
On  the 8th day after my vaccine my left arm started to swell,  turned very red,  feel achy & itched terribly. It has been 2 days of this side effect so far as of today.
The patient is a 70 year old male with PMH including HTN, HLD, and NIDDM2. He was sent to the ED by his PCP for possible monoclonal antibody infusion. In the ED, he was noticed to be hypoxic with a saturation of 87% on R/A and required oxygen. He did test positive for Covid-19. He received the Moderna vaccine in January/February 2021. His inflammatory markers were elevated and CXR showed bilateral infiltrates. He recieved decadron IV and IVF and he is admitted to the medical floors.
Same day of vax, the pt became lethargic, fever, cold and clammy, starred into space. It was noted increased respirations and wheezing. Pulse was 168, respirations 58. Paramedic examined child and the child was acting normal. Lungs are cleared and the child was given Motrin. Child began acting fussy and decreased fever.
Pt has a localized, red & cellulite reaction on UOQ (L) Gluteal. KINRIX (DTaP/IPV) was given on 6-26-12 at 2pm. Mom noticed slight redness on 6-27-12 but did not bring child in to clinic until 6-28-12. No abx given, apply heat.
Tinnitus; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 57-year-old male patient received BNT162b2 (BNT162B2), on 01Apr2022 as dose 4 (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: Bnt162b2 (Dose 1), for Covid-19 immunization; Bnt162b2 (Dose 2), for Covid-19 immunization; Bnt162b2 (Dose 3), for Covid-19 immunization. The following information was reported: TINNITUS (non-serious), outcome "not recovered".  Additional information: The clinical course was reported as reporter stated, patient has been experiencing tinnitus and it has been worse since his last dose on 01Apr2022 (second booster dose). He has had 4 doses of the vaccine. Reporter also stated, he has had the Pfizer BioNTech Vaccines, the 2 doses and the 2 Booster Shots, his last Booster being 01Apr2022 and he has tinnitus. Reporter states he has read reports about side effects with tinnitus with the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Noon- began to feel like I could pass out while at work. Drove self home and lay down. 3pm- bad headache began 6pm- severe headache, chest pain started. Husband drove me to the ER. At ER, was given IV morphine, atavan, and decadron. Test done: bloodwork, EKG, and CT of head. All normal. sent home with instructions to see family doctor next day and rx for Vicodin. didn't fill it, took 4 ibuprofen every 4 hours for several days. A few days later I noticed a knot about 3" in diameter at injection site. A week later- still have headache, but only taking 2 ibuprofen every 4-6 hours.
Pt says she has had hives for a week. Has been using BENADRYL. I told her to call her dr.
facility clinic date 2. Pt had received 1st dose of vaccine before 1st clinic date at another location. Staff had pt fill out form and intended her to get 2nd dose on 3rd clinic date but brought patient to get vaccine today. Today was 21 days from 1st dose instead of 28 days. Staff will monitor patient
Felt extreme fatigue at first then head had a terrible pressure. The next day no appetite and head symptoms worse and fatigue worse. Blood sugar started to not be my normal readings. 1 month I still have symptoms especially fatigue and head pressure with the pneumonia 23 shot.
Follow-up information was received that provided patient information, date of vaccination, concomitant vaccine and hospital of vaccine administration. Information regarding Prevnar was received from a nurse regarding a 2 month old female patient who received the first dose on 29 Aug 2006 and became lethargic. The patient has a past history of being a premature baby. Indication for Prevnar was immunization. Product was administered on 29 Aug 2006. Dose regimen was 1 dose 1 time per day. Concomitant vaccine included Poliomyelitis vaccine inactivated. On 29 Aug 2006, the child received the first dose of Prevnar. Following the injection, the patient became lethargic (lethargy). It was unknown if the patient recovered from the event. No additional information was available at the time of this report. Follow-up information was received that provided patient information, date of vaccination, concomitant vaccine and hospital vaccine administration. Information regarding PREVNAR was received from a nurse regarding a 2-month-old female patient who received the first dose on 29-Aug-2006 and became lethargic. On 29-Aug-2006, the child received the first dose of PREVNAR. Following the injection, the patient became lethargic. It was unknown if the patient recovered from the event. No additional information was available at the time of this report.
passed out after receiving last administered vaccination which was the HPV vaccine. signs of seizure noted after passing out such as very tensed arms and legs and very mild convulsions. this only lasted approximately 45 seconds but happened twice within seconds of each other
Overnight, my lips became increasingly chapped and swollen. There was a gradual increase in the dryness of my lips over the last few days, but they didn't swell until last night.
I almost passed out while waiting for the adverse effects to pass. I was at work and had to leave, I had a high fever and nausea. After a few weeks I started to have breathing problems. I went to the urgent care and was sent home again. After a month or two the side effects subsided.
Patient was administered adult dose of vaccine even after  indicating on question 7 of the 2020/2021  Influenza Vaccination Screening form that he was feeling sick.
Non-stop crying 27OCT91 Sunday 430AM-11PM; t102, pt seen by MD, fluid gathering in ears; pt put on ATB; dx BOM;
vial placed in refrigerator 11/1/2021. used beyond 31 days.
my arm has a big lump; feels a little bit warm; This spontaneous case was reported by a consumer and describes the occurrence of LIMB MASS (my arm has a big lump) and FEELING HOT (feels a little bit warm) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced LIMB MASS (my arm has a big lump) and FEELING HOT (feels a little bit warm). At the time of the report, LIMB MASS (my arm has a big lump) and FEELING HOT (feels a little bit warm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced sore arm. The action taken with covid-19 vaccine was not applicable. The outcome of sore arm was not reported. This report was non-serious.
Nausea, Vomiting, Hypotension BP ~ 96/60, pre syncope, ringing in the ears, transient vision loss, diaphoresis, pallor.  Sx lasted approximately 45 minutes. Sx started to improve after laying down, cool compresses and drinking water.
Vaccination site lymphadenopathy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE LYMPHADENOPATHY (Vaccination site lymphadenopathy) 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 an unknown date, 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 LYMPHADENOPATHY (Vaccination site lymphadenopathy). At the time of the report, VACCINATION SITE LYMPHADENOPATHY (Vaccination site lymphadenopathy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter. Sender'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.