chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine was mislabeled with a frozen storage expiration date rather than a refrigerated one. Expiration should have read 10/03/2021 rather than 11/01/2021. On 10/29 the vaccine was administered to this employee
Administered an expired dose of Menveo; 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 ACWY-CRM NVS (Menveo) (batch number AMVA259A, expiry date 31st March 2021) for prophylaxis.   On 25th June 2021, the patient received Menveo. On 25th June 2021, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows:  The coworker administered an expired dose of Menveo to the patient, which led to expired vaccine used. No further events were reported at the time of the call. The reporter did not consent to follow up.
Patient had extensive bruising on arm, shoulder and axillary area. Dr. advised pt to discontinue ASA until bruising gone. Not convinced symptoms are related to the vaccine itself.
only one Shingrix injection in 10/11/2021; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 11th October 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 27-OCT-2022 Reporter's comment: The reporter asked if a patient had only one Shingrix injection in 11th October 2021, what was the best way to proceed. The reporter also asked if one more injection or start series over. The reporter consented to follow-up via-postal. Additional Supportive Information: Till the time of reporting the patient did not receive 2nd dose of vaccine, which led to Incomplete course of vaccination.
Information has been received from a consumer concerning a friend's child who was vaccinated with MMRII. Subsequently, the "child got autism from MMRII". The consumer reported that the pt sought medical attention. Upon internal review, autism was considered to be an "Other Important Medical Event". Additional information has been requested.
Patient received the vaccine and approximately 5 mins later she fell to the ground, felt weak and eyes rolled back for just a second but did not completely lose consciousness. She was given a chair and she sat for approx 5 mins and when she went to leave the store, she fell to the ground again.  Please note, she did not want to wait in the waiting room after the vaccine for the recommended amount of time that the pharmacist indicated.
Patient reported extreme fatigue, body aches and pains.  Large red, painful area appeared on the inside and outside of the patient's right arm (same arm both immunizations were given). Patient sought medical treatment with diagnosis of cellulitis. Treated with antibiotics.
Several days after the second dose, I had mild psoriasis inside my left elbow.  It has now spread on my left arm and also on my right inside elbow.
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient fainted a few minutes after injection. She was sitting down and fell into her fathers lap who was sitting across from her. She was out approximately 30 seconds, then woke. The patient and father said 911 call was not needed at the time. She remained sitting for next 20 min approximately and left with father who received his covid dose shortly after.
Within 30 secs of shot being injected, my throat tightened up and gave the feeling you do just before throwing up. I did not throw up. I had an empty stomach at the time, however, I feel if I had eaten...I would have thrown up from this sensation. Within 2 mins of receiving the shot the lymph nodes/glands in my neck/ear/jawline were very tight, swollen and Tender. This was on the opposite side of my body from the injection site. They are still swollen/tender two days out from injection. On day two after injection my left armpit now has a swollen, tender lymph node.
JOINT ACHES FOR 3-4 DAYS; This spontaneous report received from a patient via a social media and by a company representative concerned an 86 year old of an unspecified sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient had previously received 3 dose of covid-19 vaccine (Unspecified manufacturer) (Dose number in series: 1) (form of admin, route of admin were not reported, batch number: Unknown and expiry: Unknown) dose, start therapy date were not reported, administered for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with 3 dose of covid-19 vaccine (Unspecified manufacturer) (Dose number in series: 1). The patient received booster vaccine of covid-19 vaccine ad26.cov2.s (Dose number in series: 2) (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose, start therapy date were not reported, 1 in total administered in arm (Unspecified) for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. The patient received non-company suspect vaccine included: influenza vaccine (Flu shot) (form of admin, route of admin were not reported, batch number: Unknown and expiry: Unknown), dose, start therapy date were not reported, administered in arm (Unspecified) for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced joint aches for 3-4 days (Dose number in series: 2). It was reported that "I am 86 and had a flu shot in one arm and a 4th booster covid in the other. Only had joint aches for 3 - 4 days". The action taken with covid-19 vaccine ad26.cov2.s, and influenza vaccine was not applicable. The patient recovered from joint aches for 3-4 days. This report was non-serious.
When vaccinator changed needle to administer dose to an obese female, she inadvertently changed the needle to a 5/8 inch needle and not a 1 1/2 inch needle.  Unsure if the dose was administered into the muscle or subcutaneous tissue.
My husband & I received the COVID-19 Bivalent vaccine on 9/21/22. Husband started symptoms on 9/28/22; tested positive on 9/29/22. We wore masks & distanced at home. I started having symptoms on 10/2/22 & tested positive on 10/3/22. Symptoms were as follows: runny nose, sneezing, coughing, sinus headache, low-grade fever. Felt like I had a bad head cold. My doctor advised me to use OTC treatments - Mucinex for head cold symptoms & Delsym for coughing. Symptoms continued for 5 days or so; felt back to normal about day 14.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pin at injection site for 2 days), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (fatigue lasting 7 days) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042l20a and 001b21a) for COVID-19 vaccination. Concurrent medical conditions included Kidney failure chronic since 01-Nov-2016 and Hypertension since 1991. Concomitant products included LOSARTAN POTASSIUM (LOSARTIN), AMLODIPINE, ATORVASTATIN, CURCUMA LONGA (TURMERIC [CURCUMA LONGA]) and ACETAMINOPHEN for an unknown indication. On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pin at injection site for 2 days), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (fatigue lasting 7 days). On 19-Mar-2021, VACCINATION SITE PAIN (Pin at injection site for 2 days) had resolved. On 20-Mar-2021, CHILLS (Chills) and HEADACHE (Headache) had resolved. On 24-Mar-2021, FATIGUE (fatigue lasting 7 days) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. This case was linked to MOD-2021-014165.
In the evening I went swimming and felt really tired so I cut it short. Next morning I went running and I felt exhausted, so I cut it short as well, as the day progressed I called in at work because I was extremely tired. My body was generally achy and I started with a headache. By noon I took some Tylenol and Motrin and took a nap by 2PM I felt fine. I might have had a slight fever no thermometer available, unable to check. Mostly was chills and the extreme fatigue my main symptoms.
Urticaria w/in 24 hrs of DTP inject; child was atopic having had eczema; This was the 2nd DTP;
a rash began to appear on the armpit and upper arm that received the vaccine. The rash was bright red, swollen, and had bumpy spots as well as flat patches. A finer red rash spread across her collar bone. The rash then spread to the left arm. It also appeared on the inside of her arms and thighs.  The pediatrician said it was ok to get the second dose (the rash was present). After that 2nd dose the rash spread and worsened. I will fill out a second VAERS form to document what happened after the second dose. She is still suffering with a bad rash on her body that is terribly painful, raw, and her skin is shedding.
Wife came down with the shingles 7 days after husband had shingles vaccination (VZV).
Drug ineffective; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 at 15:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 45 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Codine, reaction(s): "Known allergies: Codine". The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown", described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 20Feb2023 to 21Feb2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: As per the available information the causality of the events drug ineffective and covid-19 with the suspect can not be ruled out completely.
A couple days after first immunization patient developed decreased sense of smell and taste. Worsened after second immunization on 6/4/2021. Trial of doxycycline and saline rinses without improvement. Saw ENT. MRI brain and olfactory recommended. No improvement 10/11/2021
fever, chills, body ache, headache, fatigue, extreme pain in injected arm from 12-36 hrs post vaccine.  bruising at injection site and swollen lymph nodes to present.
Patient had fever, chills and vomiting. The symptoms started 2 hours after vaccination and resolved by next morning.
rash covering their whole body; received their first dose of VAQTA, along with MMR II and VARlVAX; This spontaneous report as received from a physician refers to a 12 month old patient. The patient's medical history, concurrent conditions and concomitant therapies were not provided.     On an unknown date, the patient was vaccinated with hepatitis a vaccine, inactivated(VAQTA) lot # T013205 expiration date 03-DEC-2021; 0.5 milliliter per intramuscular route along with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) and varicella virus vaccine live (oka/merck)(VARIVAX), all for prophylaxis (strength, dose, route, lot# and expiration date were not provided).      On an unknown date, the patient experienced a rash covering their whole body. The outcome of the event was not provided.  The causal relationship between the event and the suspect therapies was not provided. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: T013205; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
This case was reported by a consumer via call center representative and described the occurrence of teeth chattering in a 59-year-old male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced teeth chattering. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the teeth chattering was recovered/resolved. It was unknown if the reporter considered the teeth chattering to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's wife. The patient began to experience extreme shivering around 1:00 AM after receiving the SHINGRIX vaccine approximately 2 months before the date of reporting. The patient's teeth were chattering too. The patient took Tylenol and the symptoms resolved the next day. The patient was not with the reporter at the time of the reporting. The reporter was unable to obtain additional information. The reporter did not consent to follow-up.
DVT (deep vein thrombosis) in right medial subclavian; superficial thrombosis in right proximal basilic vein; right arm swelling in the setting of receiving her Pfizer covid vaccine in the right arm 1 week prior; This is a spontaneous report received from a contactable healthcare professional. A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in arm right in Mar2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. Medical history included hyperlipidemia, acute pancreatitis, May-Thurner syndrome, and allergies: penicillin, IV contrast. Concomitant medications included drospirenone, ethinylestradiol betadex clathrate (YAZ), fenofibrate, and levothyroxine. Patient is not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. Patient was seen at the ED for right arm swelling in the setting of receiving her Pfizer COVID vaccine in the right arm 1 week prior. She was found to have a DVT (deep vein thrombosis) in right medial subclavian and superficial thrombosis in right proximal basilic vein. The events started on 17Mar2021 09:00. AE resulted in emergency room/department or urgent care. Patient was recovering from the events. Treatment for AEs include anticoagulation.  Information about lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of subject vaccine cannot be excluded for the DVT and other reported events, based on temporal relationship.  However the reported events may likely represent intercurrent medical conditions in this patient. There is very limited information provided in this report.  This case will be reassessed upon receipt of follow-up information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Pt developed fever, viral type exanthem.Febrile seizure lasting 2-3 mins.Rash looked like day 1 of varicella, but fever progressed and rash became more dense. LP - 2 WBC, 90 RBC, Prot 22, glc 62, no growth, no vesicles.Diarrhea, not eating.
muscle weakness; joint pain; bilateral ear pain that wakes her up; bilateral ear pain that wakes her up; states her arm hurt; fatigue/ she was very tired/ tired all day; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Aug2021 (Lot number: EW0196) at the age of 56 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "covid 19", start date: Jan2021 (unspecified if ongoing), notes: she is a previously recovered Covid patient, states she had Covid in Jan2021. The patient's concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 05Aug2021, outcome "recovering", described as "fatigue/ she was very tired/ tired all day"; MUSCULAR WEAKNESS (non-serious) with onset 06Aug2021, outcome "recovering", described as "muscle weakness"; ARTHRALGIA (non-serious) with onset 06Aug2021, outcome "recovering", described as "joint pain"; EAR PAIN (non-serious), INSOMNIA (non-serious) all with onset 06Aug2021, outcome "recovering" and all described as "bilateral ear pain that wakes her up"; PAIN IN EXTREMITY (non-serious) with onset 06Aug2021, outcome "recovering", described as "states her arm hurt".  Additional Information: Caller states she wants to report some lasting side effects from Pfizer Covid vaccine, received first dose 5Aug2021, states she tried twice to do the online thing but would not submit. Event Details: Caller states she is a previously recovered Covid patient, states she had Covid in Jan2021, states her doctor recommended one of the vaccines, states she got the vaccine on 5Aug2021 and that first day she expected some kind of reaction, states she was very tired, states she went to bed early and was fine, states the second night, on Friday, 6Aug2021, she was tired all day, states her arm hurt but was bearable, caller states she wanted to explain that when she had Covid in Jan2021, she had this bilateral ear pain, states on that Friday and for a number of nights afterwards she was waking up with that same bilateral ear pain that she had not experienced in months, caller states she is an active person, but is still having some muscle weakness and fatigue and joint pain, states that there is some improvement but she is not back to her pre vaccine self. Caller states her husband has not had any of these reactions, and he had Covid in Jan2021 as well and they received vaccines within minutes of each other. Time the Vaccination was given for Second Dose in 16:30. Anatomical Location of Administration of Pfizer vaccine considered as suspect: LEFT ARM. Patient had no Emergency Room and Physician Office visit. Prior Vaccinations patient had no other vaccinations within four weeks prior to the first administration date of the suspect vaccine.  Follow-up attempts are completed. No further information is expected.
Extreme pain at site of vaccination, sweating, body paid and discomfort for the next 3 days shortness of breath.
PATIENT DEVELOPED HIVES "ALL OVER" LATER IN THE EVENING, AFTER GETTING PNEUMOCOCCAL VACCINE. (AM) "ITCHY" PO BENADRYL PO CLARITIN BENADRYL CREAM
Witnessed seizure about 9-10 minutes after administration of second covid shot. I work in the ER, so my treatment was immediate. I woke up to the doctor taking care of me saying "it looks like you had a reaction to the vaccine, you had a seizure after it was administered" I was observed and discharged home with supervision after about 2 hours, but the events directly after the seizure are unclear. I do know due to second account, i was placed on a cardiac monitor, seizure pads needed to be placed on stretcher, my vital signs were monitored, routine labs were drawn, i was treated with ativan for the seizure, and i came out of my post ictal period wa shorter than previous seizures, as well as my seizure length. My previous average seizure length was 5-7 minutes, this seizure was described to me as between 2-3 minutes.  When I did start to remember things, I said I felt like I had a small fever, and i did have a very low grade fever of about 99.3. The following day, it was hard to distinguish the symptoms felt by many of my coworkers (achy joints, fever, headache) because I was fatigued from the seizure the night before, but I did feel "feverish", and opted to take anti pyretics on the event my seizure threshold was lowered from fever and recent seizure. I also had joint pain, but it's hard to say if this was related to the vaccine as i (reportedly) fell to the floor suddenly and struck my head along with a good slam to the rest of my body. 2 moths later, I again had a seizure in the presence of ER healthcare providers. I did test positive for the antibodies after donating blood before my first dose, which was 12/18/20.
always seems like the syringes are out of place like the holder itself is not holding them in place; cut my finger; syringe flange broke into 3 different pieces/bottom glass part broke and cut my finger; broken syringe; This spontaneous report as received from a nurse and refers to a female patient (medical assistante) of unknown age. The patient concurrent condition and concomitant medicaitons were not reported. On 14-OCT-2022 (reported as" today"), the medical assistent was given to the patient (MARRS # 2210USA005747) hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # U031056, expiration date 16-JUN-2024 (dose and route of administration were not reported) and the bottom glass part broke and cut her finger. The hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) syringe flange broke into 3 different pieces. She was able to give the full dose and had gloves. It was also reported that when open a new package of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) "it always seems that the actually syringes in the packaging are always loose" and "seems like the syringes are out of place like the holder itself is not holding them in place". The causality assessment was not provided.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2210USA005747:MSD
This spontaneous report was received from an office manager and refers to a 4 year-old patient of unknown gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history reported. On 10-NOV-2016, the patient was vaccinated with the first improperly stored dose of VARIVAX, lot number M027885 with an expiration date on 30-JUN-2018 (dose, route and anatomical location was not reported) for prophylaxis. The vaccine was exposed to temperature of 7.7 Fahrenheit (F) during 24 hours. There was no previous temperature excursion. No adverse effects were reported. No data logger was involved. This is one of several reports from the same source. Additional information has been requested.
Localized swelling, redness and itching. MEDROL pack, PEPCID 2 mg, Loratadine 10 mg, and hydrocortisone cream prescribed.
Administered incorrect dosage 0.25 ml IM instead of administering 0.5 ml IM correct dosage.