chrisvoncsefalvay/vaers-outcomes huggingface dataset:
38 days between 1st and 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (38 days between 1st and 2nd dose) in a 62-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 014M20A) 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) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (38 days between 1st and 2nd dose). On 01-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (38 days between 1st and 2nd dose) had resolved.            No concomitant medications were reported.  No Treatment information was provided.   This case was linked to MOD21-133817 (E2B Linked Report).; Sender's Comments:  MOD21-133817:
sz 21JAN99 w/eye fixed to right, arms tonic, body stiff, drooling, unresponsive;lasted 5-8min, had post-ictal drowsiness;afeb;diarrhea 5-6x/day x 3 days, watery, no blood;MD exam 1hr p/episode-pt nl;
Received vaccine at 1600 on 1/14/2021. Woke up on 1/15/21 with nausea, vomiting, and headache. These symptoms improved by 1/16/2021 but continued to have HA all day on 1/16.  Symptoms resolved on 1/17/2021.
Psoriasis type plaques on bilateral base of hairline.  I have no history of psoriasis plaques ever in my past.  This occurred within 48 Hours of getting vaccine - developing overnight from day 1 to day 2.  Additionally sequala including a rash on back of neck with subsequent lymphedema at site.    Rash and plaques cleared by vaccine #2.  This happened again after Vaccine #2 with increased rash and plaques.
Vaccine (Moderna) given on 4/2 On 4/17, patient noted back pain radiating toward abdomen. Developed rash in same area of pain on 4/19- Seen on 4/20 and diagnosed with Herpes Zoster.  Followed on 4/23 with same diagnosis.
Persistant cough, dyspnea, sweats, myalgias, mental staus changes and diarrhea, still resoving
got real sick; Initial information received on 28-Nov-2020 regarding an unsolicited valid non-serious case received from a patient's parents via social media.  This case involves a male patient of unknown age who got real sick (illness) a day after getting INFLUENZA VACCINE [Flu Shot].  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got real sick (illness) a day after getting INFLUENZA VACCINE.  No laboratories details reported.  It was not reported if the patient received a corrective treatment.  The outcome of event was unknown.  There will be no information about batch number for this case.
Within a couple of hours, my shoulder hurt at the injection site. Over the next few days, it was as if I had pulled a muscle in my shoulder. I experienced significant discomfort and decreased mobility for the next month. Now, six weeks later, I am almost completely recovered, with very minor remaining mobility limitation and muscle weakness.
expired dose of ACTHIB was administered with no reported adverse events; Initial information received on 07-Mar-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves an unknown age and unknown gender patient to whom expired dose of HIB (PRP/T) VACCINE [ACT-HIB] was administered with no reported adverse events.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On 07-Mar-2023, the patient received suspect HIB (PRP/T) VACCINE powder and solvent for solution for injection at a dose of 0.5 ml once (lot number not reported, expiry date: 05-Mar-2023, 01-Apr-2023) via unknown route in unknown administration site for immunization.  On 07-Mar-2023 expired dose of acthib was administered with no reported adverse events (expired product administered) same day latency following the administration of HIB (PRP/T) VACCINE.  Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
swelling/heat/soreness left underarm that is still ongoing despite taking regular ibuprofen
patient fainted for seated position and fell face forward onto the floor 5 minutes after receiving vaccine. hit chin and chipped tooth. patient cleared by EMS to leave with her mom and seek medical treatment on their own.
flu like symptoms; This case was reported by a nurse via sales rep and described the occurrence of influenza-like symptoms in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not was reported. The age group selected as per vaccine specification.  The patient reported flu like symptoms after receiving a dose of shingrix. This case was linked with cases US2019AMR165394 and US2019AMR165395, reported by the same reporter.
Hives traveling over entire body continuing until present day. 1 year 5 months so far.
Very cranky all evening, awake most of night, in AM had facial hives, swollen nose, raspy voice, hives spread all day, saw PMD at 17:00 on 3/9/05 with rash all over, that night had marked redness, swelling of left leg. Treated with Benadryl after seeing PMD. Rash better on Thursday. Friday had rash on face only. Symptoms cleared by Monday. Pt was adopted and has an unk vaccination history. All information is from parent.
Tongue swelling, sore throat, oral/facial rash. Tested positive for strep infection, which resolved with antibiotics. Orofacial rash remains and patient plans to follow up with physician.
Red, peeling skin rash on left side of face/forehead/neck.  Pt states it is getting worse and that it stings and itches.  It started the next day following the vaccination.  So far, the peeling rash is localized on the left face. It is not on the trunk or extremities.   Patient has not tried any treatments or sought medical attention.  He tried making an appointment with his primary care provider, but the earliest he could get in is on 9/24/21.  I advised him to see a provider at an immediate care facility for further evaluation, due to the reaction not improving and getting worse.
acute DVT of left peroneal vein (in the left calf); This is a spontaneous report from a non-contactable consumer (patient).  This 49-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number not provided), via an unknown route, on 29Apr2021 11:30 (at the age of 49-year-old) at single dose in the left arm for COVID-19 immunisation. No relevant medical history was provided. No other vaccine was received in four weeks. Relevant concomitant medications included ibuprofen (ADVIL 12 HOUR). From 03May2021, the patient developed sharp, piercing pain in my left calf over several days. The frequency increased the early morning (06:00-09:00) of 09May2021 so she contacted her primary care physician to discuss what she thought might be an indicator of deep vein thrombosis (DVT). She presented to the Emergency Room the morning of 09May2021 and was diagnosed with acute DVT of left peroneal vein (in the left calf). She was given blood thinner. Pre-vaccination and post-vaccination COVID tests were not performed. The patient was recovering from the events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
6/7/22-Patient stated she is immunocompromised and received Moderna (0.25ml) in error when she should have received Moderna (0.5ml). Patient was given two (0.25ml) doses of Moderna to equal the (0.5ml) full dose for immunocompromised patients.
Room was literally spinning; I feel a little weird,; Got hot and cold; Still not feeling 100%...felt a little sick; Arm was a little sore; fever; Chills; Head got so bad, I was in tears; Very pale and lips were pale; Dizzy; This spontaneous case was reported by a consumer and describes the occurrence of MUCOSAL DISCOLOURATION (Very pale and lips were pale), DIZZINESS (Dizzy), VERTIGO (Room was literally spinning), FEELING ABNORMAL (I feel a little weird,) and FEELING OF BODY TEMPERATURE CHANGE (Got hot and cold) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 02-Mar-2021, the patient experienced DIZZINESS (Dizzy). On 03-Mar-2021, the patient experienced MUCOSAL DISCOLOURATION (Very pale and lips were pale), VERTIGO (Room was literally spinning), FEELING ABNORMAL (I feel a little weird,), FEELING OF BODY TEMPERATURE CHANGE (Got hot and cold), MALAISE (Still not feeling 100%...felt a little sick), VACCINATION SITE PAIN (Arm was a little sore), PYREXIA (fever), CHILLS (Chills) and HEADACHE (Head got so bad, I was in tears). The patient was treated with PARACETAMOL (TYLENOL) on 03-Mar-2021 at a dose of 1 dosage form. At the time of the report, MUCOSAL DISCOLOURATION (Very pale and lips were pale), DIZZINESS (Dizzy), VERTIGO (Room was literally spinning), FEELING ABNORMAL (I feel a little weird,), FEELING OF BODY TEMPERATURE CHANGE (Got hot and cold), MALAISE (Still not feeling 100%..felt a little sick), VACCINATION SITE PAIN (Arm was a little sore), PYREXIA (fever), CHILLS (Chills) and HEADACHE (Head got so bad, I was in tears) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported
The COVID-19 vaccine (Lot number FH8028 with expiration of 2/28/22) was given after it's beyond use date of 1/15/2022. Outcomes of giving the vaccine after the BUD unknown.
No additional AE/PQC details provided.; RN that was calling to report temperature excursion that was intermittent beginning 7/28/2020, but not previously reported, involving PROQUAD states that there have been administered doses.; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender.  No information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies was provided.  It was reported that temperature excursion was intermittent beginning 28-AUG-2020, but not previously reported, involving Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD).   On 03-AUG-2020, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # S031882 with expiration date of 07-APR-2021, 0.5 milliliter, for prophylaxis.   It was stated that the vaccines underwent a temperature excursion of -14 degrees Celsius (°C) to -10 °C (max -9.5°C) for a total of 38 hours and 30 minutes. No previous temperature excursion occurred. The call was because of a "data logger."   ; Sender's Comments:  US-009507513-2008USA014788:
severe muscle and joint pains lasting up to the present and continuing indefinitely., fatigue, fever, and chills,
no additional AE's were reported; patient was administered an expired dose of PNEUMOVAX 23.; This spontaneous report was received from a physician and refers to a patient of unknown age and gender.  The patient's pertinent medical history, drug reactions/allergies, and concomitant therapies were not reported.  On 30-MAR-2023, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, 0.5 milliliter, lot # U027357 (Lot number U027357 has been verified to be valid for pneumococcal vaccine, polyvalent [23-valent]), expiration date: 25-MAR-2023 (expired product administered) intramuscularly, as prophylaxis.
Debilitating fatigue and muscle soreness for 2 days from 1'st shot; Debilitating fatigue and muscle soreness for 3 days from 2nd shot; also developed numbness in 3 toes on right foot after 2nd shot
This spontaneous report was received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not provided. On unknown dates, the patients were vaccinated with doses of oral, ROTATEQ (route, lot numbers and expiration dates were not provided). On unknown dates, there was incorrect product storage as an unspecified number of patients received doses of oral, ROTATEQ improperly stored. No adverse effect was reported. It was unknown if the patients sought medical attention. At the time of the report, the patients status was unknown. This is one of several reports received from the same source. Additional information has been requested.
Admitted to hospital with covid pneumonia on 9/10/21. Patient was fully vaccinated with doses of Pfizer covid vaccine with first dose on 2/1/2021 and second dose on 2/23/21. Patient eventually required intubation and ultimately expired on 9/23/21.
An attorney alleges that an 2 month old male received his first dose of DTaP in Jan 1990 and subsequently developed mental retardation. He received his second, third and booster doses in March 1990, May 1990 and Jun 1991 respectively. It is alleged that following his "first round" of vaccinations, the child's language and learning abilities and his capacity for accomplishing basic tasks gradually deteriorated. The child, age 12 at the date of this report, has been diagnosed as mentally retarded and he "will always require care provided by others." At the date this was reported, no further information was available. The attorney alleged that the child received DTaP in 1990 and June 1991; however, Acel-Imune was not distributed until January of 1992.
BREAKTHROUGH COVID INFECTION. TESTED POSITIVE ON 08/27/2021. PATIENT FULLY VACCINATED ON 03/16/2021.
Initial information received on 26-Jul-2018 regarding an unsolicited valid non-serious case received from a Pharmacist. This case involves a 23 years old patient who was accidentally given expired vaccine, no AE, TENIVAC. This was medication error case due to expired vaccine used. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant therapies were reported. On 25-Jul-2018, the patient received a dose of 0.5 ml of suspect TENIVAC lot U5280AA, exp date 15-March-2018 via intramuscular route in the left arm. The patient had not reported any side effect. Lab data and corrective treatment: not applicable. The patient outcome is reported as not Applicable for patient was accidentally given expired vaccine. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Gave 0.3ml dose instead of 0.5 ml dose.  Called patient and repeated second dose 11/10/21 with 0.5ml dose Janssen.  NO adverse effects from either dose.
Mild headache and fatigue one hour after administration. Sore at injection site at 0500hrs the next day, no redness or swelling but pain radiated down arm into fingers and upward into shoulder, neck and base of skull.  By 1900hrs headache worsened to almost migraine level and began joint and muscle aching. By 2200 began chilling, unable to get warm, a large thick quilt folded 4 times and a thick wool blanket), no fever, started mild nausea.  Day 3 (Christmas) Painful to walk and move, all joints and spine ached to the point of tears-Tylenol did not help, headache at migraine level, extremely fatigued. Day four (Saturday) the same reported symptoms to doctor. Sunday woke around 0800 with slight headache and slight  muscle aches by noon all symptoms were gone,  This was my first shot of the Moderna Vaccine.
Within 24 hours, the pt developed an injection site reaction characterized by a swollen, red, warm raised area. The pt was recovering from bronchitis and this put a strain on her breathing. She was seen in the ER and administered and unspecified breathing treatment. This is 1 of 2 pt's from this facility who experienced an injection site reaction. Additional information received on 12/22/99 from the physician indicated that the pt received nebulized breathing treatment in the ER and recovered.
30 minutes after vaccine patient was experiencing blurred vision and dizziness. 2 hours after vaccine, dizziness and blurred vision had resolved, but the patient was feeling weak and nauseous.
Headache, Myalgia, UrticariaPruiritus, swelling left axillary node, extreme fatigue Narrative: Is at work today but still feels achy; see the symptoms above
Fever 101.4 starting sat 4/11,  vomiting (sat), diarrhea fri 4/9, 99.5 temp sun 4/12
cold sensation on nose; tingling sensation on face and tongue; had a feeling on face like getting Novacaine, It did not stop me from doing my daily activities; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (cold sensation on nose), PARAESTHESIA (tingling sensation on face and tongue) and HYPOAESTHESIA (had a feeling on face like getting Novacaine, It did not stop me from doing my daily activities) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included IBUPROFEN (ADVIL [IBUPROFEN]) for an unknown indication.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 15-Feb-2021, the patient experienced FEELING COLD (cold sensation on nose), PARAESTHESIA (tingling sensation on face and tongue) and HYPOAESTHESIA (had a feeling on face like getting Novacaine, It did not stop me from doing my daily activities). On 15-Feb-2021, FEELING COLD (cold sensation on nose), PARAESTHESIA (tingling sensation on face and tongue) and HYPOAESTHESIA (had a feeling on face like getting Novacaine, It did not stop me from doing my daily activities) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Patient stated that she got her 1st moderna dose on 15Feb2021 to right dominant hand via IM injection. Within minutes of getting shot I felt cold sensation on nose and tingling sensation on face and tongue it dissipated and resolved same day. she had a feeling on face like getting Novacaine. It did not stop her from doing her daily activities.
Employee seen in Occupational Health clinic today (12/03/2015) and reports having a spontaneous abortion.
I had chills, fever 102, and feeling fatigue. just laid in bed all day. Contacted my daughter and he called in medication for fever and fatigue.
Body aches from head to toes, lethargy,  headaches, coughing, anxiety  heart palpation, sore throat, lack of appetite
Fever spiking to 102.6, headache, confusion, loss of appetite, nausea, extreme tiredness(slept for almost 24 hours straight).  I took Tylenol for the fever, which did not really work until 3/4/2021.  Fever finally broke to just under 100 by 3/4/2021 and was gone completely by 3/5/2021. Headache was gone by 3/4/2021.  All other symptoms have subsided by 3/5/2021.
Within 5-10 minutes of receiving vaccines developed generalized urticaria, angioedema involving the lips and earlobes, coughing, and a flare in his eczema.  Treated with dose of epinephrine, albuterol by nebulizer, oral prednisolone, and oral antihistamine.  Resolution of symptoms 30 minutes after dose of epinephrine. 9/2/08-records received for DOS 8/21/08-C/O rash after vaccination. Generalized pruritus and red rash which blanches with pressure. Scattered urticarial lesions over face, scalp, trunk and extremities. Acute onset of generalized pruritis, cough, swelling of lips and ear lobes within 5 minutes of receiving vaccinations.  Assessment: Anaphylaxis. Adverse drug effect of vaccines.
Arm doesn't feel normal, I feel like I'm getting some inflammation at the place where I got the shot; Fever symptoms; Feel very weak; Headache, getting a bit stronger; Fingers I feel like I'm getting some feelings of inflammation going down from my arm to my fingers; Arm was getting weak; My arm swell and I kind of felt like it's getting heavy; constant pain in the area and I can't raise my arm even when I'm driving the car; Arm was getting weak; My arm swell and I kind of felt like it's getting heavy; constant pain in the area and I can't raise my arm even when I'm driving the car; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A patient of unspecified age and gender received bnt162b2 ( PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number and Expiration date was not reported) dose 2 via an unspecified route of administration on an unspecified date as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received first dose of bnt162b2 ( PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number and Expiration date was not reported) via an unspecified route of administration on an unspecified date at first dose single dose for covid-19 immunisation and experienced arm was, felt like it swell. On an unspecified date the patient experienced arm doesn't feel normal, I feel like  getting some inflammation at the place where  got the shot, fever symptoms, feel very weak, headache, getting a bit stronger, fingers I feel like I am getting some feelings of inflammation going down from my arm to my fingers, arm was getting weak; my arm swell and i kind of felt like it's getting heavy; constant pain in the area and I can't raise my arm even when i'm driving the car. The outcome of events was unknown.    Information on the lot/batch number has been requested.
Headache, Injection site soreness/fatigue Narrative: Day 2 Injection site soreness Day 3 Headache Day 4 Fatigue
Left hand swelling, red and swollen area around deltoid injection site. 4th in series. Last received March 2000
10 hrs afterwards I had the worst chills I have ever had for 2 hrs then my body was on fire for 2 hrs. I was drenched in sweat had to change my clothes twice and a severe headache. I felt some mild discomfort in my breathing and I was extremely thirsty.  All of this lasted about 5 hrs